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Evaluating the Feasibility, Acceptability and Pre Testing the Impact of a Self-management and Tele Monitoring Program for COPD Patients in Lebanon

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
self-management program
Sponsored by
University of Paris 13
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Adult,18 years of age or older
  • Male or female
  • Outpatient
  • With moderate (GOLD 2) or severe (Gold 3) COPD.
  • Cognitively capable, with an adequate health status to participate in the study according to the clinical consensus between nurses and physicians.

Exclusion Criteria:

  • Patients diagnosed with lung cancer
  • Patients who have cognitive problems related to memory loss or speech disorders that would not allow a constructive exchange

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Acceptability
    Based on "Pre-Referral intervention team inventory" we have created our own evaluation grid composed of 9 questions. Answers ranged between strongly agree to strongly disagree.
    Adoption
    Based on "adoption of information technology innovation" we have created our own evaluation grid composed of 5 questions. Patient must choose one of the proposed answers that best suits him/her.
    Adequacy
    Based on "Parenting strategies questionnaire" we have created our own qualitative evaluation grid composed of three questions. the patient must assign a score to each question that varies between 0 and 10.
    Fidelity
    Fidelity will be assessed by comparing the protocol of the intervention with what will be done in the field.
    Cost
    Based on "Utilization and Cost Questionnaire" we have created our own qualitative evaluation grid composed of 4 questions.
    Coverage
    Based on "levels of institutionalization". it is composed of 15 multiple-choice questions. Based on the average of the responses, the score will range from a low to high level of institutionalization.

    Secondary Outcome Measures

    Impact on quality of life
    We will use the COPD assessment test (CAT) to evaluate the quality of life of participants. CAT is composed of eight questions measured on a 5-point scale, with a score ranging from 0 to 40. Highest scores indicate a higher impact of COPD on patients' quality of life.
    Rehospitalization rate
    The hospital register of each participant will be consulted to collect and evaluate the number of hospitalizations during the year preceding the intervention and during the intervention
    Emergency visit
    The hospital register of each participant will be consulted to collect and evaluate the emergency room visits during the year preceding the intervention and during the intervention
    Respiratory health status
    COPD clinical questionnaire (CCQ). It consists of 10 questions in 3 domains (symptoms, functional state, and mental state). All scores ranged from 0 to 6, and the final score is the mean of the sum of all items, with a higher score indicating a lower health status.
    Anxiety
    "Hospital Anxiety and Depression" (HAD). It includes 14 rated items from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), resulting in two scores (maximum score of each score = 21).

    Full Information

    First Posted
    December 4, 2019
    Last Updated
    December 11, 2019
    Sponsor
    University of Paris 13
    Collaborators
    Lebanese University, Hotel Dieu Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04196699
    Brief Title
    Evaluating the Feasibility, Acceptability and Pre Testing the Impact of a Self-management and Tele Monitoring Program for COPD Patients in Lebanon
    Official Title
    Evaluating the Feasibility, Acceptability and Pre Testing the Impact of a Self-management and Tele Monitoring Program for COPD Patients in Lebanon: Protocol for a Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 10, 2020 (Anticipated)
    Primary Completion Date
    May 28, 2020 (Anticipated)
    Study Completion Date
    June 28, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Paris 13
    Collaborators
    Lebanese University, Hotel Dieu Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    Chronic obstructive pulmonary disease (COPD) has a significant impact on quality of life and is costly to the health care system. It has been demonstrated that a self-management program improves quality of life, but programs are not universally available and telehealth interventions can provide home-based support, but have mixed results. The aims of this study are to (1) assess the feasibility and acceptability of a 6 weeks' educational program related to self-management with remote monitoring for Lebanese COPD patients; (2) pre-test its impact on quality of life, emergency visits, and rate of rehospitalization, and (3) to make recommendations for a future randomized trial.
    Detailed Description
    This study aims to evaluate the feasibility, acceptability and pre-test the impact of a nursing consultation and tele-monitoring in Lebanon. It will be conducted at the Hôtel-Dieu de France (HDF) hospital, one of the largest university hospitals in Beirut, and will use quantitative and qualitative methods in pre- and post-intervention to collect data over a period of 3 months. Data will be collected by two researchers. A consent form will be signed by each participant prior to the intervention. Patients will be informed about the purpose of the study, the course of the intervention, and the freedom to withdraw from the study at any time. Their consent for the video recording will also be taken. This study is the first to evaluate the application of telehealth to optimize COPD management in Lebanon. The results of this study will provide evidence regarding the efficacy and feasibility of this approach for Lebanese patients with moderate to severe COPD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    self-management program
    Intervention Description
    Our intervention will be based on the following framework and will consist of 3 phases : Phase I: At the end of a medical consultation, the doctor will offer the patient the opportunity to benefit from a nursing consultation and remote monitoring to better manage his COPD. A nursing consultation will be scheduled during which the nurse will explain the procedure, obtain the written consent of the patient, and develop an educational diagnosis with the participation of the patient. Phase II: During the next six weeks education sessions will be provide to the participants and a telephone number will be available in case of emergency and for any additional information. Phase III: A final consultation will be scheduled at the nurse office to evaluate the patient's achievements and modify his/her educational assessment. A telephone follow-up will be conducted after one month to assess the maintenance of learning.
    Primary Outcome Measure Information:
    Title
    Acceptability
    Description
    Based on "Pre-Referral intervention team inventory" we have created our own evaluation grid composed of 9 questions. Answers ranged between strongly agree to strongly disagree.
    Time Frame
    2 month
    Title
    Adoption
    Description
    Based on "adoption of information technology innovation" we have created our own evaluation grid composed of 5 questions. Patient must choose one of the proposed answers that best suits him/her.
    Time Frame
    2 month
    Title
    Adequacy
    Description
    Based on "Parenting strategies questionnaire" we have created our own qualitative evaluation grid composed of three questions. the patient must assign a score to each question that varies between 0 and 10.
    Time Frame
    2 month
    Title
    Fidelity
    Description
    Fidelity will be assessed by comparing the protocol of the intervention with what will be done in the field.
    Time Frame
    2 month
    Title
    Cost
    Description
    Based on "Utilization and Cost Questionnaire" we have created our own qualitative evaluation grid composed of 4 questions.
    Time Frame
    2 month
    Title
    Coverage
    Description
    Based on "levels of institutionalization". it is composed of 15 multiple-choice questions. Based on the average of the responses, the score will range from a low to high level of institutionalization.
    Time Frame
    2 month
    Secondary Outcome Measure Information:
    Title
    Impact on quality of life
    Description
    We will use the COPD assessment test (CAT) to evaluate the quality of life of participants. CAT is composed of eight questions measured on a 5-point scale, with a score ranging from 0 to 40. Highest scores indicate a higher impact of COPD on patients' quality of life.
    Time Frame
    3 month
    Title
    Rehospitalization rate
    Description
    The hospital register of each participant will be consulted to collect and evaluate the number of hospitalizations during the year preceding the intervention and during the intervention
    Time Frame
    3 month
    Title
    Emergency visit
    Description
    The hospital register of each participant will be consulted to collect and evaluate the emergency room visits during the year preceding the intervention and during the intervention
    Time Frame
    3 month
    Title
    Respiratory health status
    Description
    COPD clinical questionnaire (CCQ). It consists of 10 questions in 3 domains (symptoms, functional state, and mental state). All scores ranged from 0 to 6, and the final score is the mean of the sum of all items, with a higher score indicating a lower health status.
    Time Frame
    3 month
    Title
    Anxiety
    Description
    "Hospital Anxiety and Depression" (HAD). It includes 14 rated items from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), resulting in two scores (maximum score of each score = 21).
    Time Frame
    3 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult,18 years of age or older Male or female Outpatient With moderate (GOLD 2) or severe (Gold 3) COPD. Cognitively capable, with an adequate health status to participate in the study according to the clinical consensus between nurses and physicians. Exclusion Criteria: Patients diagnosed with lung cancer Patients who have cognitive problems related to memory loss or speech disorders that would not allow a constructive exchange

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluating the Feasibility, Acceptability and Pre Testing the Impact of a Self-management and Tele Monitoring Program for COPD Patients in Lebanon

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