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Information-Motivation-Behavioral Skills Model-based Intervention to Domiciliary Non-invasive Ventilation of Patients

Primary Purpose

Hypercapnic Respiratory Failure, Noninvasive Ventilation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Information-Motivation-Behavioral skills (IMB) model-based intervention
Control - usual care
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypercapnic Respiratory Failure focused on measuring Chronic Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Noninvasive Ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • (1) CHRF (i.e., PaCO2 ≥ 7 kPa or 52.5 mmHg) for at least 4 weeks, and
  • (2) using domiciliary NIV for ≥ 4 weeks, and
  • (3) non-adherer (i.e., used domiciliary NIV for < 4 hours per night or < 70% of days or with a mean daily use < 5 hours per day in the last 2 weeks)

Exclusion Criteria:

  • (1) known psychiatric disorders except anxiety and depression; or
  • (2) diseases limiting life expectancy to ≤ one year; or
  • (3) active malignancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention

    Control - usual care

    Arm Description

    There will be a respiratory team, same as the usual care, responsible for patients requiring domiciliary NIV in the intervention group. The IMB model-based intervention of this study is a six-week program consisted of a one-hour face-to-face home visit in the first week, two 20-minute telephone follow-ups in the second and fourth weeks, and a half-hour face-to-face follow-up at hospital in the sixth week, and a telephone consultation hotline during office hours. There are three major components including information, motivation and behavioral skill interventions as proposed by the IMB model and will be deliberately arranged in the different sessions.

    There is a respiratory team of health care professionals responsible for patients requiring domiciliary NIV. The team is led by a Medical Consultant and with respiratory nurse(s) as team members who are responsible for assisting patients or their family to initiate domiciliary NIV and teaching the relevant technical skills. The nurse will provide an one-hour face-to-face session to introduce the choices of domiciliary NIV and teach the patient or his/her family on how to operate and maintain the ventilator, interface and accessories, and also how to handle the common problems such as leakage and pressure sore in hospital before discharge. Commercial leaflet or booklet according to the choice of ventilator with information of the ventilator, interface, accessories and the ventilator company will be provided to the patient.

    Outcomes

    Primary Outcome Measures

    Domiciliary NIV adherence
    the records from the software fitted on the subject's NIV machine for the past two weeks will be reviewed to determine adherence or non-adherence, and assessed for the percentage of days with usage of at least 4 hours per night and the mean of daily use.
    Domiciliary NIV adherence
    the records from the software fitted on the subject's NIV machine for the past two weeks will be reviewed to determine adherence or non-adherence, and assessed for the percentage of days with usage of at least 4 hours per night and the mean of daily use.
    Domiciliary NIV adherence
    the records from the software fitted on the subject's NIV machine for the past two weeks will be reviewed to determine adherence or non-adherence, and assessed for the percentage of days with usage of at least 4 hours per night and the mean of daily use.
    Domiciliary NIV adherence
    the records from the software fitted on the subject's NIV machine for the past two weeks will be reviewed to determine adherence or non-adherence, and assessed for the percentage of days with usage of at least 4 hours per night and the mean of daily use.

    Secondary Outcome Measures

    Venous bicarbonate (HCO3-) level
    estimation for level of hypercapnia
    Venous bicarbonate (HCO3-) level
    estimation for level of hypercapnia
    Venous bicarbonate (HCO3-) level
    estimation for level of hypercapnia
    Chinese Pittsburgh Sleep Quality Index (CPSQI)
    19-item self-reported measures assess the participant's sleep quality over last month. Seven component scores including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction can be obtained from the items. The component scores range from 0 (no problem) to 3 (severe problem) and the overall score ranges from 0 to 21 with a higher score indicating a poorer sleep quality.
    Chinese Pittsburgh Sleep Quality Index (CPSQI)
    19-item self-reported measures assess the participant's sleep quality over last month. Seven component scores including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction can be obtained from the items. The component scores range from 0 (no problem) to 3 (severe problem) and the overall score ranges from 0 to 21 with a higher score indicating a poorer sleep quality.
    Chinese Pittsburgh Sleep Quality Index (CPSQI)
    19-item self-reported measures assess the participant's sleep quality over last month. Seven component scores including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction can be obtained from the items. The component scores range from 0 (no problem) to 3 (severe problem) and the overall score ranges from 0 to 21 with a higher score indicating a poorer sleep quality.
    Chinese Pittsburgh Sleep Quality Index (CPSQI)
    19-item self-reported measures assess the participant's sleep quality over last month. Seven component scores including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction can be obtained from the items. The component scores range from 0 (no problem) to 3 (severe problem) and the overall score ranges from 0 to 21 with a higher score indicating a poorer sleep quality.
    Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
    49 items assess the participants's health-related quality of life (QoL) from completely untrue, mostly untrue, sometimes true , mostly true, always true. The scores will be transformed between 0 and 100 with higher values indicating a better health-related quality of life.
    Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
    49 items assess the participants's health-related quality of life (QoL) from completely untrue, mostly untrue, sometimes true , mostly true, always true. The scores will be transformed between 0 and 100 with higher values indicating a better health-related quality of life.
    Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
    49 items assess the participants's health-related quality of life (QoL) from completely untrue, mostly untrue, sometimes true , mostly true, always true. The scores will be transformed between 0 and 100 with higher values indicating a better health-related quality of life.
    Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
    49 items assess the participants's health-related quality of life (QoL) from completely untrue, mostly untrue, sometimes true , mostly true, always true. The scores will be transformed between 0 and 100 with higher values indicating a better health-related quality of life.
    Hospital admissions and survival rate
    record the number of hospital admissions
    Hospital admissions and survival rate
    record the number of hospital admissions

    Full Information

    First Posted
    August 9, 2021
    Last Updated
    August 18, 2021
    Sponsor
    The University of Hong Kong
    Collaborators
    University Grants Committee, Hong Kong, Hospital Authority, Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05008211
    Brief Title
    Information-Motivation-Behavioral Skills Model-based Intervention to Domiciliary Non-invasive Ventilation of Patients
    Official Title
    Effectiveness of an Information-Motivation-Behavioral Skills Model-based Intervention on Adherence to Domiciliary Non-invasive Ventilation of Patients With Chronic Hypercapnic Respiratory Failure: A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 16, 2021 (Anticipated)
    Primary Completion Date
    August 15, 2024 (Anticipated)
    Study Completion Date
    October 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Hong Kong
    Collaborators
    University Grants Committee, Hong Kong, Hospital Authority, Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Domiciliary non-invasive ventilation (NIV) is a standard care for improving survival rates of selected patients with chronic hypercapnic respiratory failure (CHRF) and to improve the patients' hypercapnia, sleep quality, health-related quality of life (QoL). Adherence is an important factor affecting clinical effectiveness of domiciliary NIV. Our previous study has noted the associations between poor domiciliary NIV adherence and increased number of clinical adverse events (p = 0.004) and increased hospitalization requiring acute NIV salvage (p = 0.042). However, there are very limited studies on adherence to domiciliary NIV in patients with CHRF. The only interventional study was a single-group pre-test post-test study and lack of a theoretical framework for guiding the intervention. This study is employing an Information-Motivation-Behavioral skills (IMB) model-based intervention to improve inhalation adherence in a group of chronic obstructive pulmonary disease (COPD) patients.
    Detailed Description
    The study design is a multi-center, 2-arm single-blind randomized controlled trial. The intervention group will receive an Information-Motivation-Behavioral (IMB) model-based intervention while the control group will receive the usual care. Usual Care: There is a respiratory team of health care professionals responsible for patients requiring domiciliary non-invasive ventilation (NIV). The team is led by a Medical Consultant and with respiratory nurse(s) as team members who are responsible for assisting patients or their family to initiate domiciliary NIV and teaching the relevant technical skills. The nurse will provide an one-hour face-to-face session to introduce the choices of domiciliary NIV and teach the patient or his/her family on how to operate and maintain the ventilator, interface and accessories, and also how to handle the common problems such as leakage and pressure sore in hospital before discharge. Commercial leaflet or booklet according to the choice of ventilator with information of the ventilator, interface, accessories and the ventilator company will be provided to the patient. Intervention: There will be a respiratory team, same as the usual care, responsible for patients requiring domiciliary NIV in the intervention group. The IMB model-based intervention of this study is a six-week program consisted of a one-hour face-to-face home visit in the first week, two 20-minute telephone follow-ups in the second and fourth weeks, and a half-hour face-to-face follow-up at hospital in the sixth week, and a telephone consultation hotline during office hours.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercapnic Respiratory Failure, Noninvasive Ventilation
    Keywords
    Chronic Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Noninvasive Ventilation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    There will be a respiratory team, same as the usual care, responsible for patients requiring domiciliary NIV in the intervention group. The IMB model-based intervention of this study is a six-week program consisted of a one-hour face-to-face home visit in the first week, two 20-minute telephone follow-ups in the second and fourth weeks, and a half-hour face-to-face follow-up at hospital in the sixth week, and a telephone consultation hotline during office hours. There are three major components including information, motivation and behavioral skill interventions as proposed by the IMB model and will be deliberately arranged in the different sessions.
    Arm Title
    Control - usual care
    Arm Type
    Placebo Comparator
    Arm Description
    There is a respiratory team of health care professionals responsible for patients requiring domiciliary NIV. The team is led by a Medical Consultant and with respiratory nurse(s) as team members who are responsible for assisting patients or their family to initiate domiciliary NIV and teaching the relevant technical skills. The nurse will provide an one-hour face-to-face session to introduce the choices of domiciliary NIV and teach the patient or his/her family on how to operate and maintain the ventilator, interface and accessories, and also how to handle the common problems such as leakage and pressure sore in hospital before discharge. Commercial leaflet or booklet according to the choice of ventilator with information of the ventilator, interface, accessories and the ventilator company will be provided to the patient.
    Intervention Type
    Other
    Intervention Name(s)
    Information-Motivation-Behavioral skills (IMB) model-based intervention
    Intervention Description
    A six-week programme
    Intervention Type
    Other
    Intervention Name(s)
    Control - usual care
    Intervention Description
    he nurse will provide an one-hour face-to-face session to introduce the choices of domiciliary NIV and teach the patient or his/her family on how to operate and maintain the ventilator, interface and accessories, and also how to handle the common problems
    Primary Outcome Measure Information:
    Title
    Domiciliary NIV adherence
    Description
    the records from the software fitted on the subject's NIV machine for the past two weeks will be reviewed to determine adherence or non-adherence, and assessed for the percentage of days with usage of at least 4 hours per night and the mean of daily use.
    Time Frame
    baseline
    Title
    Domiciliary NIV adherence
    Description
    the records from the software fitted on the subject's NIV machine for the past two weeks will be reviewed to determine adherence or non-adherence, and assessed for the percentage of days with usage of at least 4 hours per night and the mean of daily use.
    Time Frame
    3rd month
    Title
    Domiciliary NIV adherence
    Description
    the records from the software fitted on the subject's NIV machine for the past two weeks will be reviewed to determine adherence or non-adherence, and assessed for the percentage of days with usage of at least 4 hours per night and the mean of daily use.
    Time Frame
    6th month
    Title
    Domiciliary NIV adherence
    Description
    the records from the software fitted on the subject's NIV machine for the past two weeks will be reviewed to determine adherence or non-adherence, and assessed for the percentage of days with usage of at least 4 hours per night and the mean of daily use.
    Time Frame
    12th month
    Secondary Outcome Measure Information:
    Title
    Venous bicarbonate (HCO3-) level
    Description
    estimation for level of hypercapnia
    Time Frame
    baseline
    Title
    Venous bicarbonate (HCO3-) level
    Description
    estimation for level of hypercapnia
    Time Frame
    3rd month
    Title
    Venous bicarbonate (HCO3-) level
    Description
    estimation for level of hypercapnia
    Time Frame
    6th month
    Title
    Chinese Pittsburgh Sleep Quality Index (CPSQI)
    Description
    19-item self-reported measures assess the participant's sleep quality over last month. Seven component scores including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction can be obtained from the items. The component scores range from 0 (no problem) to 3 (severe problem) and the overall score ranges from 0 to 21 with a higher score indicating a poorer sleep quality.
    Time Frame
    baseline
    Title
    Chinese Pittsburgh Sleep Quality Index (CPSQI)
    Description
    19-item self-reported measures assess the participant's sleep quality over last month. Seven component scores including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction can be obtained from the items. The component scores range from 0 (no problem) to 3 (severe problem) and the overall score ranges from 0 to 21 with a higher score indicating a poorer sleep quality.
    Time Frame
    3rd month
    Title
    Chinese Pittsburgh Sleep Quality Index (CPSQI)
    Description
    19-item self-reported measures assess the participant's sleep quality over last month. Seven component scores including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction can be obtained from the items. The component scores range from 0 (no problem) to 3 (severe problem) and the overall score ranges from 0 to 21 with a higher score indicating a poorer sleep quality.
    Time Frame
    6th month
    Title
    Chinese Pittsburgh Sleep Quality Index (CPSQI)
    Description
    19-item self-reported measures assess the participant's sleep quality over last month. Seven component scores including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction can be obtained from the items. The component scores range from 0 (no problem) to 3 (severe problem) and the overall score ranges from 0 to 21 with a higher score indicating a poorer sleep quality.
    Time Frame
    12th month
    Title
    Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
    Description
    49 items assess the participants's health-related quality of life (QoL) from completely untrue, mostly untrue, sometimes true , mostly true, always true. The scores will be transformed between 0 and 100 with higher values indicating a better health-related quality of life.
    Time Frame
    baseline
    Title
    Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
    Description
    49 items assess the participants's health-related quality of life (QoL) from completely untrue, mostly untrue, sometimes true , mostly true, always true. The scores will be transformed between 0 and 100 with higher values indicating a better health-related quality of life.
    Time Frame
    3rd month
    Title
    Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
    Description
    49 items assess the participants's health-related quality of life (QoL) from completely untrue, mostly untrue, sometimes true , mostly true, always true. The scores will be transformed between 0 and 100 with higher values indicating a better health-related quality of life.
    Time Frame
    6th month
    Title
    Chinese Severe Respiratory Insufficiency questionnaire (CSRI)
    Description
    49 items assess the participants's health-related quality of life (QoL) from completely untrue, mostly untrue, sometimes true , mostly true, always true. The scores will be transformed between 0 and 100 with higher values indicating a better health-related quality of life.
    Time Frame
    12th month
    Title
    Hospital admissions and survival rate
    Description
    record the number of hospital admissions
    Time Frame
    baseline
    Title
    Hospital admissions and survival rate
    Description
    record the number of hospital admissions
    Time Frame
    12th month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: (1) CHRF (i.e., PaCO2 ≥ 7 kPa or 52.5 mmHg) for at least 4 weeks, and (2) using domiciliary NIV for ≥ 4 weeks, and (3) non-adherer (i.e., used domiciliary NIV for < 4 hours per night or < 70% of days or with a mean daily use < 5 hours per day in the last 2 weeks) Exclusion Criteria: (1) known psychiatric disorders except anxiety and depression; or (2) diseases limiting life expectancy to ≤ one year; or (3) active malignancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    YU Sau Fung Doris, PhD
    Phone
    3917 6319
    Email
    dyu1@hku.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    YU Sau Fung Doris, PhD
    Organizational Affiliation
    School of Nursing, LKS Faculty of Medicine, HKU
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Only study investigators and research assistants involved in the study will have access to the data.
    Citations:
    PubMed Identifier
    8143712
    Citation
    Hormann C, Baum M, Putensen C, Mutz NJ, Benzer H. Biphasic positive airway pressure (BIPAP)--a new mode of ventilatory support. Eur J Anaesthesiol. 1994 Jan;11(1):37-42.
    Results Reference
    result
    PubMed Identifier
    14738245
    Citation
    Chu CM, Yu WC, Tam CM, Lam CW, Hui DS, Lai CK; Hong Kong Home Ventilation Registry; Hong Kong Thoracic Society. Home mechanical ventilation in Hong Kong. Eur Respir J. 2004 Jan;23(1):136-41. doi: 10.1183/09031936.03.00017803.
    Results Reference
    result
    PubMed Identifier
    27560387
    Citation
    Simonds AK. Home Mechanical Ventilation: An Overview. Ann Am Thorac Soc. 2016 Nov;13(11):2035-2044. doi: 10.1513/AnnalsATS.201606-454FR.
    Results Reference
    result
    PubMed Identifier
    22420583
    Citation
    Cheng SL, Chan VL, Chu CM. Compliance with home non-invasive ventilation. Respirology. 2012 May;17(4):735-6. doi: 10.1111/j.1440-1843.2012.02169.x.
    Results Reference
    result
    PubMed Identifier
    22171400
    Citation
    Motor Neurone Disease: The Use of Non-Invasive Ventilation in the Management of Motor Neurone Disease [Internet]. London: National Institute for Health and Clinical Excellence (NICE); 2010 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK65383/
    Results Reference
    result
    PubMed Identifier
    7638799
    Citation
    Simonds AK, Elliott MW. Outcome of domiciliary nasal intermittent positive pressure ventilation in restrictive and obstructive disorders. Thorax. 1995 Jun;50(6):604-9. doi: 10.1136/thx.50.6.604.
    Results Reference
    result
    PubMed Identifier
    8275718
    Citation
    Leger P, Bedicam JM, Cornette A, Reybet-Degat O, Langevin B, Polu JM, Jeannin L, Robert D. Nasal intermittent positive pressure ventilation. Long-term follow-up in patients with severe chronic respiratory insufficiency. Chest. 1994 Jan;105(1):100-5. doi: 10.1378/chest.105.1.100.
    Results Reference
    result
    PubMed Identifier
    11179136
    Citation
    Mehta S, Hill NS. Noninvasive ventilation. Am J Respir Crit Care Med. 2001 Feb;163(2):540-77. doi: 10.1164/ajrccm.163.2.9906116. No abstract available.
    Results Reference
    result
    PubMed Identifier
    12212984
    Citation
    Shneerson JM, Simonds AK. Noninvasive ventilation for chest wall and neuromuscular disorders. Eur Respir J. 2002 Aug;20(2):480-7. doi: 10.1183/09031936.02.00404002.
    Results Reference
    result
    PubMed Identifier
    7633704
    Citation
    Meecham Jones DJ, Paul EA, Jones PW, Wedzicha JA. Nasal pressure support ventilation plus oxygen compared with oxygen therapy alone in hypercapnic COPD. Am J Respir Crit Care Med. 1995 Aug;152(2):538-44. doi: 10.1164/ajrccm.152.2.7633704.
    Results Reference
    result
    PubMed Identifier
    1756837
    Citation
    Elliott MW, Mulvey DA, Moxham J, Green M, Branthwaite MA. Domiciliary nocturnal nasal intermittent positive pressure ventilation in COPD: mechanisms underlying changes in arterial blood gas tensions. Eur Respir J. 1991 Oct;4(9):1044-52.
    Results Reference
    result
    PubMed Identifier
    2376246
    Citation
    Ambrosino N, Montagna T, Nava S, Negri A, Brega S, Fracchia C, Zocchi L, Rampulla C. Short term effect of intermittent negative pressure ventilation in COPD patients with respiratory failure. Eur Respir J. 1990 May;3(5):502-8.
    Results Reference
    result
    PubMed Identifier
    21861914
    Citation
    Duiverman ML, Wempe JB, Bladder G, Vonk JM, Zijlstra JG, Kerstjens HA, Wijkstra PJ. Two-year home-based nocturnal noninvasive ventilation added to rehabilitation in chronic obstructive pulmonary disease patients: a randomized controlled trial. Respir Res. 2011 Aug 23;12(1):112. doi: 10.1186/1465-9921-12-112.
    Results Reference
    result
    PubMed Identifier
    29962738
    Citation
    Suraj KP, Jyothi E, Rakhi R. Role of Domiciliary Noninvasive Ventilation in Chronic Obstructive Pulmonary Disease Patients Requiring Repeated Admissions with Acute Type II Respiratory Failure: A Prospective Cohort Study. Indian J Crit Care Med. 2018 Jun;22(6):397-401. doi: 10.4103/ijccm.IJCCM_61_18.
    Results Reference
    result
    PubMed Identifier
    28839495
    Citation
    Blankenburg T, Benthin C, Pohl S, Bramer A, Kalbitz F, Lautenschlager C, Schutte W. Survival of Hypercapnic Patients with COPD and Obesity Hypoventilation Syndrome Treated with High Intensity Non Invasive Ventilation in the Daily Routine Care. Open Respir Med J. 2017 Jun 30;11:31-40. doi: 10.2174/1874306401711010031. eCollection 2017.
    Results Reference
    result
    PubMed Identifier
    26746384
    Citation
    Duiverman ML, Windisch W, Storre JH, Wijkstra PJ. The role of NIV in chronic hypercapnic COPD following an acute exacerbation: the importance of patient selection? Ther Adv Respir Dis. 2016 Apr;10(2):149-57. doi: 10.1177/1753465815624645. Epub 2016 Jan 8.
    Results Reference
    result
    PubMed Identifier
    25066329
    Citation
    Kohnlein T, Windisch W, Kohler D, Drabik A, Geiseler J, Hartl S, Karg O, Laier-Groeneveld G, Nava S, Schonhofer B, Schucher B, Wegscheider K, Criee CP, Welte T. Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease: a prospective, multicentre, randomised, controlled clinical trial. Lancet Respir Med. 2014 Sep;2(9):698-705. doi: 10.1016/S2213-2600(14)70153-5. Epub 2014 Jul 24.
    Results Reference
    result
    PubMed Identifier
    20388753
    Citation
    Dreher M, Storre JH, Schmoor C, Windisch W. High-intensity versus low-intensity non-invasive ventilation in patients with stable hypercapnic COPD: a randomised crossover trial. Thorax. 2010 Apr;65(4):303-8. doi: 10.1136/thx.2009.124263.
    Results Reference
    result
    PubMed Identifier
    19213769
    Citation
    McEvoy RD, Pierce RJ, Hillman D, Esterman A, Ellis EE, Catcheside PG, O'Donoghue FJ, Barnes DJ, Grunstein RR; Australian trial of non-invasive Ventilation in Chronic Airflow Limitation (AVCAL) Study Group. Nocturnal non-invasive nasal ventilation in stable hypercapnic COPD: a randomised controlled trial. Thorax. 2009 Jul;64(7):561-6. doi: 10.1136/thx.2008.108274. Epub 2009 Feb 12.
    Results Reference
    result
    PubMed Identifier
    26418151
    Citation
    Altintas N. Update: Non-Invasive Positive Pressure Ventilation in Chronic Respiratory Failure Due to COPD. COPD. 2016;13(1):110-21. doi: 10.3109/15412555.2015.1043520. Epub 2015 Sep 29.
    Results Reference
    result
    PubMed Identifier
    28528348
    Citation
    Murphy PB, Rehal S, Arbane G, Bourke S, Calverley PMA, Crook AM, Dowson L, Duffy N, Gibson GJ, Hughes PD, Hurst JR, Lewis KE, Mukherjee R, Nickol A, Oscroft N, Patout M, Pepperell J, Smith I, Stradling JR, Wedzicha JA, Polkey MI, Elliott MW, Hart N. Effect of Home Noninvasive Ventilation With Oxygen Therapy vs Oxygen Therapy Alone on Hospital Readmission or Death After an Acute COPD Exacerbation: A Randomized Clinical Trial. JAMA. 2017 Jun 6;317(21):2177-2186. doi: 10.1001/jama.2017.4451.
    Results Reference
    result
    PubMed Identifier
    24157199
    Citation
    Struik FM, Lacasse Y, Goldstein RS, Kerstjens HA, Wijkstra PJ. Nocturnal noninvasive positive pressure ventilation in stable COPD: a systematic review and individual patient data meta-analysis. Respir Med. 2014 Feb;108(2):329-37. doi: 10.1016/j.rmed.2013.10.007. Epub 2013 Oct 14.
    Results Reference
    result
    PubMed Identifier
    24912564
    Citation
    Borel JC, Pepin JL, Pison C, Vesin A, Gonzalez-Bermejo J, Court-Fortune I, Timsit JF. Long-term adherence with non-invasive ventilation improves prognosis in obese COPD patients. Respirology. 2014 Aug;19(6):857-65. doi: 10.1111/resp.12327. Epub 2014 Jun 9.
    Results Reference
    result
    PubMed Identifier
    27698560
    Citation
    Dretzke J, Moore D, Dave C, Mukherjee R, Price MJ, Bayliss S, Wu X, Jordan RE, Turner AM. The effect of domiciliary noninvasive ventilation on clinical outcomes in stable and recently hospitalized patients with COPD: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2016 Sep 16;11:2269-2286. doi: 10.2147/COPD.S104238. eCollection 2016.
    Results Reference
    result
    PubMed Identifier
    17126543
    Citation
    Farrero E, Prats E, Manresa F, Escarrabill J. Outcome of non-invasive domiciliary ventilation in elderly patients. Respir Med. 2007 Jun;101(6):1068-73. doi: 10.1016/j.rmed.2006.10.005. Epub 2006 Nov 28.
    Results Reference
    result
    PubMed Identifier
    28721033
    Citation
    Callegari J, Magnet FS, Taubner S, Berger M, Schwarz SB, Windisch W, Storre JH. Interfaces and ventilator settings for long-term noninvasive ventilation in COPD patients. Int J Chron Obstruct Pulmon Dis. 2017 Jun 28;12:1883-1889. doi: 10.2147/COPD.S132170. eCollection 2017.
    Results Reference
    result
    PubMed Identifier
    20059598
    Citation
    Chang AY, Marsh S, Smith N, Neill A. Long-term community non-invasive ventilation. Intern Med J. 2010 Nov;40(11):764-71. doi: 10.1111/j.1445-5994.2010.02171.x.
    Results Reference
    result
    PubMed Identifier
    24482704
    Citation
    Ulger AF, Poyraz B, Gulec Balbay E, Binay S. Our experience of 200 patients: usage and maintenance of long-term oxygen therapy and non-invasive ventilation devices at home. Int J Clin Exp Med. 2014 Jan 15;7(1):170-6. eCollection 2014.
    Results Reference
    result
    PubMed Identifier
    25524958
    Citation
    Gale NK, Jawad M, Dave C, Turner AM. Adapting to domiciliary non-invasive ventilation in chronic obstructive pulmonary disease: a qualitative interview study. Palliat Med. 2015 Mar;29(3):268-77. doi: 10.1177/0269216314558327. Epub 2014 Dec 18.
    Results Reference
    result
    PubMed Identifier
    26235150
    Citation
    Ennis J, Rohde K, Chaput JP, Buchholz A, Katz SL. Facilitators and Barriers to Noninvasive Ventilation Adherence in Youth with Nocturnal Hypoventilation Secondary to Obesity or Neuromuscular Disease. J Clin Sleep Med. 2015 Dec 15;11(12):1409-16. doi: 10.5664/jcsm.5276.
    Results Reference
    result
    PubMed Identifier
    29531743
    Citation
    Mansell SK, Cutts S, Hackney I, Wood MJ, Hawksworth K, Creer DD, Kilbride C, Mandal S. Using domiciliary non-invasive ventilator data downloads to inform clinical decision-making to optimise ventilation delivery and patient compliance. BMJ Open Respir Res. 2018 Mar 3;5(1):e000238. doi: 10.1136/bmjresp-2017-000238. eCollection 2018.
    Results Reference
    result
    PubMed Identifier
    24598245
    Citation
    Mayberry LS, Osborn CY. Empirical validation of the information-motivation-behavioral skills model of diabetes medication adherence: a framework for intervention. Diabetes Care. 2014;37(5):1246-53. doi: 10.2337/dc13-1828. Epub 2014 Mar 5.
    Results Reference
    result
    PubMed Identifier
    25559697
    Citation
    Cooperman NA, Richter KP, Bernstein SL, Steinberg ML, Williams JM. Determining Smoking Cessation Related Information, Motivation, and Behavioral Skills among Opiate Dependent Smokers in Methadone Treatment. Subst Use Misuse. 2015 Apr;50(5):566-81. doi: 10.3109/10826084.2014.991405. Epub 2015 Jan 5.
    Results Reference
    result
    PubMed Identifier
    29879495
    Citation
    Nelson LA, Wallston KA, Kripalani S, LeStourgeon LM, Williamson SE, Mayberry LS. Assessing barriers to diabetes medication adherence using the Information-Motivation-Behavioral skills model. Diabetes Res Clin Pract. 2018 Aug;142:374-384. doi: 10.1016/j.diabres.2018.05.046. Epub 2018 Jun 4.
    Results Reference
    result
    PubMed Identifier
    17652681
    Citation
    Malatesha G, Singh NK, Bharija A, Rehani B, Goel A. Comparison of arterial and venous pH, bicarbonate, PCO2 and PO2 in initial emergency department assessment. Emerg Med J. 2007 Aug;24(8):569-71. doi: 10.1136/emj.2007.046979.
    Results Reference
    result
    PubMed Identifier
    16155782
    Citation
    Tsai PS, Wang SY, Wang MY, Su CT, Yang TT, Huang CJ, Fang SC. Psychometric evaluation of the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) in primary insomnia and control subjects. Qual Life Res. 2005 Oct;14(8):1943-52. doi: 10.1007/s11136-005-4346-x.
    Results Reference
    result
    PubMed Identifier
    24759325
    Citation
    Ho RT, Fong TC. Factor structure of the Chinese version of the Pittsburgh sleep quality index in breast cancer patients. Sleep Med. 2014 May;15(5):565-9. doi: 10.1016/j.sleep.2013.10.019. Epub 2014 Feb 18.
    Results Reference
    result
    PubMed Identifier
    20819144
    Citation
    Cheung LM, Wong WS. The effects of insomnia and internet addiction on depression in Hong Kong Chinese adolescents: an exploratory cross-sectional analysis. J Sleep Res. 2011 Jun;20(2):311-7. doi: 10.1111/j.1365-2869.2010.00883.x. Epub 2010 Aug 31.
    Results Reference
    result
    PubMed Identifier
    20408932
    Citation
    Wong WS, Fielding R. Prevalence of insomnia among Chinese adults in Hong Kong: a population-based study. J Sleep Res. 2011 Mar;20(1 Pt 1):117-26. doi: 10.1111/j.1365-2869.2010.00822.x.
    Results Reference
    result
    PubMed Identifier
    28851800
    Citation
    Chen R, Guan L, Wu W, Yang Z, Li X, Luo Q, Liang Z, Wang F, Guo B, Huo Y, Yang Y, Zhou L. The Chinese version of the Severe Respiratory Insufficiency questionnaire for patients with chronic hypercapnic chronic obstructive pulmonary disease receiving non-invasive positive pressure ventilation. BMJ Open. 2017 Aug 28;7(8):e017712. doi: 10.1136/bmjopen-2017-017712.
    Results Reference
    result
    Links:
    URL
    http://www.fmshk.org/database/hkmd/hkmd201609.pdf
    Description
    Cheung PS, Chu CM. Non-invasive ventilation for COPD hospital and home use. The Hong Kong Medical Diary 2016; 21(9): 21-3.
    URL
    https://www.hilarispublisher.com/open-access/an-update-on-domiciliary-noninvasive-ventilation-2161-105X.1000234.pdf
    Description
    Comer DM. An update on domiciliary non-invasive ventilation. J Pulm Respir Med 2014; 5: 234. doi:10.4172/2161-105x.1000234
    URL
    https://apps.who.int/iris/bitstream/handle/10665/42682/9241545992.pdf
    Description
    Sabate E. Adherence to long-term therapies: Evidence for action. Geneva, Switzerland: World Health Organization, 2003.
    URL
    https://www.wiley.com/en-us/Social+Psychological+Foundations+of+Health+and+Illness-p-9780631225157
    Description
    Fisher WA, Fisher JD, Harman J. The Information-Motivation-Behavioral Skills Model: A general social psychological approach to understanding and promoting health behavior. In Suls, Wallston (Eds.), Social psychological foundations of health and illnes
    URL
    https://synapse.koreamed.org/articles/1058496
    Description
    Kim YI, Park JS. Development and Evaluation of a Joint Health Self-management Program for the Elderly with Knee Osteoarthritis in Communities: Applying the IMB Model. J Korean Acad Community Health Nurs 2017; 28(1): 55-68.
    URL
    https://www.hkcgn.org/images/userfiles/newsletter/Newsletter_Issue28_8pp_r1.pdf
    Description
    To KW, Lee FKI. The effect of a theory-driven educational-intervention for improving adherence to inhalation therapy in patients with chronic obstructive pulmonary disease: A pilot study. Presented in Hong Kong College of Gerontology Nursing Scientifi
    URL
    https://books.google.com.hk/books/about/An_Introduction_to_Randomized_Controlled.html?id=0wrDQgAACAAJ&redir_esc=y
    Description
    Matthews JNS. An introduction to randomized controlled clinical trials. London: Arnold, 2000.
    URL
    https://www.amazon.com/Laboratory-Diagnostic-Tests-Nursing-Implications/dp/0130305197
    Description
    Kee JL. Laboratory and diagnostic tests with nursing implications, 6th ed.. Upper Saddle River, New Jersey: Prentice Hall, 2002.
    URL
    https://oxford.universitypressscholarship.com/view/10.1093/acprof:oso/9780195152968.001.0001/acprof-9780195152968
    Description
    Singer JD, Willett JB. Applied longitudinal data analysis: modelling change and event occurrence. New York: Oxford University Press, 2003.

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