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Nurse-led Medication Self-management Intervention in the Improvement of Medication Adherence

Primary Purpose

Heart Diseases, CKD, Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motivational tteaching
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Diseases

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: +18 years old or over, Patients with at least two of the identified comorbidities (Hypertension, Chronic painful condition, Cancer, Inflammatory connective tissue disorders, Diabetes, Lipid disorder, Dyspepsia and gastroenteritis, Heart disease, Chronic obstructive pulmonary disease, Stroke and cerebrovascular disease , chronic kidney disorder , Asthma Thyroid disorders, Anemia, Chronic liver disease, Depression, Epilepsy, Anxiety & other stress related disorders), (3) having at least one medication prescribed for a chronic condition over at least the 3 months prior to inclusion in the study, Non-adherence to medications, as defined by scoring zero on the 8-item Medication Adherence Report Scale (Morisky -8)(29), Independently managing their medications (i.e., not rely on a care taker), Able to speak or understand English/Arabic, Able and willing to receive phone calls, and Capable of providing a written informed consent to participate in the study. Exclusion Criteria: Being institutionalized in a long-term care facility, Planning to move away from the community in the next 6 months, Cognitive impairment (Mini-cog scores < 4), and Currently participating in research involving chronic disease management. Patients with cognitive impairment are excluded because they may not be able to provide valid answers to the questionnaires.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Educational treatment

    Standard Care

    Arm Description

    The medication self-management intervention consists of three face-to-face education sessions and two weekly telephone follow-up over 6 weeks. Intervention components are derived from an extensive review of the literature, including the related theoretical framework and current practice. Based on the extended IMB model of medication adherence, this intervention is designed to offer information related to medication treatment, motivate patients to adhere, help build medication self-management skills, and develop adherence improvement plans. The face-to-face meeting will take place in the clinical nurse specialist counselling room in NCCCR.

    Participants in the control group will continue to receive standard care from Physicians, nurses, and clinical pharmacists in the NCCCR. Physicians are the primary providers and coordinators of care for patients with chronic conditions. Physicians provide patients consultations and education regarding their diseases and treatments (typically clinician-centred) at each patient visit to the chronic disease clinic.

    Outcomes

    Primary Outcome Measures

    Medication Adherence
    The Morisky-8 is a self-reporting measure of unintentional and intentional medication non-adherent behaviors with a yes and no response. The total score of the moresky-8 ranges from 0 to 8, with a higher score representing higher adherence to medication. Approx 50% percentage change in medication adherence after intervention from baseline to 3 months as compared to control

    Secondary Outcome Measures

    Medication Knowledge
    Change medication knowledge using The Patients' Perceived Knowledge in Medication Use Questionnaire (PKMUQ). The response scale ranges from 1 = strongly disagree to 5 = strongly agree, and the response scores of all 5 items will be summed. Higher scores indicate a higher level of medication knowledge. the score will vary from 5 to 25.
    Medication beliefs
    using the Beliefs about Medication Questionnaire (BMQ 18-item)self-reported questionnaire we will assess the medication beliefs from baseline to 3 months. A 5-point Likert scale ranging from 1 = strongly disagree to 5 = strongly agree is used. A higher score indicates stronger beliefs about the corresponding concepts in each subscale. the score range would be 5 to 90.
    Medication self-efficacy
    Change in Self efficacy will be assess using the SEAMS 13 items of questionnaire. Each item has a 3-point scale ranging from 1 = not confident to 3 = very confident. The score of scale ranges from 13 to 39, with a higher medication self-efficacy by a higher score.
    Treatment burden
    The change in behavior and emotional burden using MTBQ questionnaire. Each item is scored on 6-point Likert scale, ranging from 0 = does not apply to 5 = most difficult. Scores are summed to derive a total score ranging from 0 to 50 with a higher score indicating a higher level of treatment burden.

    Full Information

    First Posted
    November 20, 2022
    Last Updated
    December 7, 2022
    Sponsor
    Hamad Medical Corporation
    Collaborators
    Medical Research Council
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05645653
    Brief Title
    Nurse-led Medication Self-management Intervention in the Improvement of Medication Adherence
    Official Title
    Nurse-led Medication Self-management Intervention in the Improvement of Medication Adherence in Adult Patients With Multi-morbidity: A Feasibility Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hamad Medical Corporation
    Collaborators
    Medical Research Council

    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
    Back ground & Aims Adult patients suffering from multimorbidity are at high risk of medication non-adherence. It has been well established that self-management support is an effective strategy to enhance medication adherence for patients with chronic conditions. However, little is known about the effect of the medication self-management intervention in Adult patients with multimorbidity. The aim of this study to evaluate the effectiveness of a nurse-led medication self-management intervention in improving medication adherence and health outcomes in adult patients with multimorbidity. Methods This study is a single centre, single-blind, two-arm randomised controlled trial. Adult patients with multi-morbidity will be recruited from NCCCR Qatar. A total of 100 participants will be randomly allocated to receive standard care or standard care plus the medication self-management intervention. The intervention will be delivered by clinical nurse specialists. The 6-week intervention includes three face-to-face education sessions (2st week, 4rd week and 6th week) and two weekly (8th week and 10 week) follow-up phone calls. Participants in the control group continue to receive all respects of standard care offered by healthcare providers, including chronic disease management, drug prescription, referral to hospital specialists, health education and consultations regarding patients' diseases and treatments during centre visits. Outcome The primary outcome is medication adherence as measured by the 8-item Medication Adherence Report Scale. Secondary outcomes include medication self-management capacity (medication knowledge, medication beliefs, and medication self-efficacy), treatment experiences (medication treatment satisfaction and treatment burden). All outcomes will be measured at baseline, immediately post-intervention (7th week), and at 3-month post-intervention.
    Detailed Description
    In terms of intervention we are giving six weeks motivational training ( 3 face face session and 2 telephonic follow ups).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Diseases, CKD, Diabetes, Cancer, Asthma, Thyroid, Hypertension

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a single Centre open label, two-arm randomized controlled trial with 1:1 randomization at the participant level. The patient population will be patients with at least two comorbidities. The patient recruitment will be done in the National Centre for Cancer Care and Research (NCCCR) in the outpatient department in the clinical nurse specialist counselling room.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Educational treatment
    Arm Type
    Experimental
    Arm Description
    The medication self-management intervention consists of three face-to-face education sessions and two weekly telephone follow-up over 6 weeks. Intervention components are derived from an extensive review of the literature, including the related theoretical framework and current practice. Based on the extended IMB model of medication adherence, this intervention is designed to offer information related to medication treatment, motivate patients to adhere, help build medication self-management skills, and develop adherence improvement plans. The face-to-face meeting will take place in the clinical nurse specialist counselling room in NCCCR.
    Arm Title
    Standard Care
    Arm Type
    No Intervention
    Arm Description
    Participants in the control group will continue to receive standard care from Physicians, nurses, and clinical pharmacists in the NCCCR. Physicians are the primary providers and coordinators of care for patients with chronic conditions. Physicians provide patients consultations and education regarding their diseases and treatments (typically clinician-centred) at each patient visit to the chronic disease clinic.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motivational tteaching
    Intervention Description
    A comprehensive assessment of adherence problems will be firstly conducted to identify the factors that affect adherence, including how and why these factors contribute to poor adherence. Medication-related knowledge and skills will be provided based on individual treatments and barriers to adherence. Motivational interviewing techniques will be used for a better understanding of patients' cognitive factors of adherence behavior.
    Primary Outcome Measure Information:
    Title
    Medication Adherence
    Description
    The Morisky-8 is a self-reporting measure of unintentional and intentional medication non-adherent behaviors with a yes and no response. The total score of the moresky-8 ranges from 0 to 8, with a higher score representing higher adherence to medication. Approx 50% percentage change in medication adherence after intervention from baseline to 3 months as compared to control
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Medication Knowledge
    Description
    Change medication knowledge using The Patients' Perceived Knowledge in Medication Use Questionnaire (PKMUQ). The response scale ranges from 1 = strongly disagree to 5 = strongly agree, and the response scores of all 5 items will be summed. Higher scores indicate a higher level of medication knowledge. the score will vary from 5 to 25.
    Time Frame
    3 months
    Title
    Medication beliefs
    Description
    using the Beliefs about Medication Questionnaire (BMQ 18-item)self-reported questionnaire we will assess the medication beliefs from baseline to 3 months. A 5-point Likert scale ranging from 1 = strongly disagree to 5 = strongly agree is used. A higher score indicates stronger beliefs about the corresponding concepts in each subscale. the score range would be 5 to 90.
    Time Frame
    3 months
    Title
    Medication self-efficacy
    Description
    Change in Self efficacy will be assess using the SEAMS 13 items of questionnaire. Each item has a 3-point scale ranging from 1 = not confident to 3 = very confident. The score of scale ranges from 13 to 39, with a higher medication self-efficacy by a higher score.
    Time Frame
    3 months
    Title
    Treatment burden
    Description
    The change in behavior and emotional burden using MTBQ questionnaire. Each item is scored on 6-point Likert scale, ranging from 0 = does not apply to 5 = most difficult. Scores are summed to derive a total score ranging from 0 to 50 with a higher score indicating a higher level of treatment burden.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: +18 years old or over, Patients with at least two of the identified comorbidities (Hypertension, Chronic painful condition, Cancer, Inflammatory connective tissue disorders, Diabetes, Lipid disorder, Dyspepsia and gastroenteritis, Heart disease, Chronic obstructive pulmonary disease, Stroke and cerebrovascular disease , chronic kidney disorder , Asthma Thyroid disorders, Anemia, Chronic liver disease, Depression, Epilepsy, Anxiety & other stress related disorders), (3) having at least one medication prescribed for a chronic condition over at least the 3 months prior to inclusion in the study, Non-adherence to medications, as defined by scoring zero on the 8-item Medication Adherence Report Scale (Morisky -8)(29), Independently managing their medications (i.e., not rely on a care taker), Able to speak or understand English/Arabic, Able and willing to receive phone calls, and Capable of providing a written informed consent to participate in the study. Exclusion Criteria: Being institutionalized in a long-term care facility, Planning to move away from the community in the next 6 months, Cognitive impairment (Mini-cog scores < 4), and Currently participating in research involving chronic disease management. Patients with cognitive impairment are excluded because they may not be able to provide valid answers to the questionnaires.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kalpana Singh, Ph.D
    Phone
    40258218
    Email
    nkalpanasingh@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Badriya Lenjawi, Ph.D
    Email
    blenjawi@hamad.qa

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Research data will be stored on a password-protected computer and backed up on a password-protected hard drive Research Department 322A 3rd floor 302. PI and Senior Biostatistician will have the access of full data

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    Nurse-led Medication Self-management Intervention in the Improvement of Medication Adherence

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