Heart FailureNCT07580508
SUPPORT-HEART-PK: Effectiveness, Implementation, and Cost-Effectiveness of a Theory-Based, RE-AIM-Informed Digital Self-Management Intervention for Heart Failure in Pakistan-A Hybrid Type 1 Effectiveness-Implementation Randomized Controlled Trial
A study testing RE-AIM-informed autonomy-competence intervention in people with Heart Failure and Chronic Heart Failure (CHF), run by Universiti Putra Malaysia at 1 site in Pakistan.
Trial summary
Medication non-adherence leads to recurrent admissions, worsening symptoms, poor quality of life, and increased healthcare costs in an already overburdened health system. Existing adherence interventions in Pakistan are limited, mostly educational, and rarely guided by behavioural theory, implementation science, or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Chronic Heart Failure (CHF)
- What is being tested?
- RE-AIM-informed autonomy-competence intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 870 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2026to 25 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Diagnosed heart failure for at least 6 months
- Prescribed ≥2 heart failure medications
- Documented medication non-adherence
- Able to provide informed consent
- Access to a smartphone
Who cannot join
- Severe psychiatric illness
- Terminal illness
- Severe cognitive impairment
- End-stage renal disease
- Participation in another intervention trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Civil Hospital Karachi, Dr. Ruth K. M. Pfau Civil Hospital Karachi
Karachi, 74600
Muhammad Arshed, 03337474464, drarshedchaudhary@gmail.com
About this study
Official title: SUPPORT-HEART-PK: Effectiveness, Implementation, and Economic Evaluation of a RE-AIM-Informed, Theory-Based Digital Self-Management Intervention for Heart Failure Management-A Hybrid Type 1 Effectiveness-Implementation Randomized Controlled Trial
Medication non-adherence leads to recurrent admissions, worsening symptoms, poor quality of life, and increased healthcare costs in an already overburdened health system. Existing adherence interventions in Pakistan are limited, mostly educational, and rarely guided by behavioural theory, implementation science, or economic evaluation.
Therefore, a culturally appropriate, RE-AIM-informed autonomy-competence intervention is needed to improve medication adherence and quality of life among heart failure patients in Pakistan, while also assessing implementation feasibility and cost-effectiveness for future scale-up.
Read the detailed description
This study will employ a type 1 hybrid effectiveness-implementation randomized controlled trial to evaluate the clinical effectiveness, implementation outcomes, and cost-effectiveness of a RE-AIM-informed autonomy-competence intervention designed to improve medication adherence and quality of life among patients with heart failure. A parallel two-arm superiority trial design with a 1:1 allocation ratio will be used, in which participants will be randomly assigned to either the intervention group or the usual care group. The trial is theoretically grounded in the Self-Determination Theory, particularly the constructs of autonomy support and competence enhancement, while implementation evaluation will be guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance).
- Conditions
- Heart Failure, Chronic Heart Failure (CHF)
- Being tested
- RE-AIM-informed autonomy-competence intervention
- Keywords
- Chronic Heart Failure, Medication adherence, Cost-effectiveness, Randomized controlled trial, RE-AIM
- Medical subject headings
- Heart Failure, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RE-AIM-informed autonomy-competence interventionBehavioural
Participants in the intervention arm will receive a digital RE-AIM-informed autonomy-competence intervention over four months. The intervention will aim to improve medication adherence by enhancing patients' autonomy, motivation, self-management confidence, and treatment competence. It will include individualized medication planning, shared decision-making, motivational counselling, adherence goal setting, structured medication education, pill-management support, symptom-monitoring guidance, problem-solving for adherence barriers, WhatsApp reminders, monthly telephonic follow-up, and reinforcement counselling. Family involvement will be encouraged where appropriate. Intervention fidelity will be monitored using delivery checklists, supervision, and periodic review.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Participants in the intervention arm will receive a digital RE-AIM-informed autonomy-competence intervention over four months. The intervention will aim to improve medication adherence by enhancing patients' autonomy, motivation, self-management confidence, and treatment competence. Receives: Behavioral: RE-AIM-informed autonomy-competence intervention |
| Control arm | No intervention | Participants in the control group will receive standard routine cardiology care, including physician consultation, medication prescription, and usual counselling, without additional digital adherence support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence (self-efficacy) in heart failure patients
The first primary outcome will be medication adherence (self-efficacy) in heart failure patients, measured using the Self-Efficacy for Appropriate Medication Use Scale Urdu version (SEAMS-U) and pill count adherence assessment. The Self-Efficacy for Appropriate Medication Use Scale (SEAMS) is a 13-item tool measuring patient confidence in medication adherence. It typically uses a 3-point Likert scale (1=not confident, 2=fairly confident, 3=extremely confident). Scores range from 13 to 39, with higher scores indicating higher self-efficacy.
Measured: 3 months
Medication adherence (objective adherence rate)
The second primary outcome is medication adherence (objective adherence rate), will also be assessed using pill count methodology. Adherence rate will be calculated as the proportion of pills taken divided by the number of pills prescribed over the previous 30 days, expressed as a percentage. An adherence rate ≥80% will be considered adequate adherence.
Measured: 3 months
Secondary outcomes (2)
Heart Failure (HF)-specific Health-Related Quality of Life (HRQoL)
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) will be used. It consists of 21 items, each scored on a 6-point Likert scale ranging from 0 to 5, where 0 indicates no impact, and 5 indicates a very severe impact of heart failure on the patient's life. The total score ranges from 0 to 105, with higher scores indicating poorer health-related quality of life. The questionnaire also includes two major subscales: the physical dimension (8 items; score range 0-40) and the emotional dimension (5 items; score range 0-25), with higher scores indicating poorer HRQoL.
Measured: 3 months
Implementation outcomes (RE-AIM domains)
Measured under the RE-AIM framework:
Reach (% participants enrolled) Effectiveness (clinical + adherence outcomes) Adoption (provider uptake) Implementation (fidelity, dose, acceptability, feasibility)
Validated tools:
Acceptability of Intervention Measure (AIM) Feasibility of Intervention Measure (FIM) Intervention Appropriateness Measure (IAM). Higher scores indicate better measures
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start15 Oct 2026 (estimated)
- Primary completion24 Feb 2027 (estimated)
- Study completion25 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It will be a two-arm randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 870 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arshed Muhammad, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580508
- Sponsor's protocol ID
- BMUUU
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study protocol, statistical plan, and results will be disseminated through publications in peer-reviewed Journals.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUPPORT-HEART-PK: Effectiveness, Implementation, and Economic Evaluation of a RE-AIM-Informed, Theory-Based Digital Self-Management Intervention for Heart Failure Management-A Hybrid Type 1 Effectiveness-Implementation Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07580508
- Acronym / sponsor ID
- BMUUU
- Conditions
- Heart Failure, Chronic Heart Failure (CHF)
- Keywords
- Chronic Heart Failure, Medication adherence, Cost-effectiveness, Randomized controlled trial, RE-AIM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 870 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 24 Feb 2027 (estimated)
- Study completion
- 25 Feb 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Medication non-adherence leads to recurrent admissions, worsening symptoms, poor quality of life, and increased healthcare costs in an already overburdened health system. Existing adherence interventions in Pakistan are limited, mostly educational, and rarely guided by behavioural theory, implementation science, or economic evaluation.
Therefore, a culturally appropriate, RE-AIM-informed autonomy-competence intervention is needed to improve medication adherence and quality of life among heart failure patients in Pakistan, while also assessing implementation feasibility and cost-effectiveness for future scale-up.
Detailed description
This study will employ a type 1 hybrid effectiveness-implementation randomized controlled trial to evaluate the clinical effectiveness, implementation outcomes, and cost-effectiveness of a RE-AIM-informed autonomy-competence intervention designed to improve medication adherence and quality of life among patients with heart failure. A parallel two-arm superiority trial design with a 1:1 allocation ratio will be used, in which participants will be randomly assigned to either the intervention group or the usual care group. The trial is theoretically grounded in the Self-Determination Theory, particularly the constructs of autonomy support and competence enhancement, while implementation evaluation will be guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- It will be a two-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: RE-AIM-informed autonomy-competence interventionParticipants in the intervention arm will receive a digital RE-AIM-informed autonomy-competence intervention over four months. The intervention will aim to improve medication adherence by enhancing patients' autonomy, motivation, self-management confidence, and treatment competence. |
| Control arm | No intervention | –Participants in the control group will receive standard routine cardiology care, including physician consultation, medication prescription, and usual counselling, without additional digital adherence support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
Key exclusion criteria (5 listed)
- Severe psychiatric illness
- Terminal illness
- Severe cognitive impairment
- End-stage renal disease
- Participation in another intervention trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RE-AIM-informed autonomy-competence interventionParticipants in the intervention arm will receive a digital RE-AIM-informed autonomy-competence intervention over four months. The intervention will aim to improve medication adherence by enhancing patients' autonomy, motivation, self-management confidence, and treatment competence. It will include individualized medication planning, shared decision-making, motivational counselling, adherence goal setting, structured medication education, pill-management support, symptom-monitoring guidance, problem-solving for adherence barriers, WhatsApp reminders, monthly telephonic follow-up, and reinforcement counselling. Family involvement will be encouraged where appropriate. Intervention fidelity will be monitored using delivery checklists, supervision, and periodic review. | Behavioural | Intervention arm |
Primary outcome
Medication adherence (self-efficacy) in heart failure patients
Time frame: 3 months
The first primary outcome will be medication adherence (self-efficacy) in heart failure patients, measured using the Self-Efficacy for Appropriate Medication Use Scale Urdu version (SEAMS-U) and pill count adherence assessment. The Self-Efficacy for Appropriate Medication Use Scale (SEAMS) is a 13-item tool measuring patient confidence in medication adherence. It typically uses a 3-point Likert scale (1=not confident, 2=fairly confident, 3=extremely confident). Scores range from 13 to 39, with higher scores indicating higher self-efficacy.
Medication adherence (objective adherence rate)
Time frame: 3 months
The second primary outcome is medication adherence (objective adherence rate), will also be assessed using pill count methodology. Adherence rate will be calculated as the proportion of pills taken divided by the number of pills prescribed over the previous 30 days, expressed as a percentage. An adherence rate ≥80% will be considered adequate adherence.
2 secondary outcomes
Heart Failure (HF)-specific Health-Related Quality of Life (HRQoL)
Time frame: 3 months
Implementation outcomes (RE-AIM domains)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. The study protocol, statistical plan, and results will be disseminated through publications in peer-reviewed Journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RE-AIM-informed autonomy-competence intervention in people with Heart Failure and Chronic Heart Failure (CHF), run by Universiti Putra Malaysia at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Arshed, Ph.D. (00923337474464, drarshedchaudhary@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (self-efficacy) in heart failure patients (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.