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NCT Number: NCT07580508

SUPPORT-HEART-PK: Effectiveness, Implementation, and Economic Evaluation of Implementation, and Theory-Based Digital Self-Management Intervention for Heart Failure Management

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.

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Key information

Conditions

Heart Failure Behavior Cardiovascular Diseases Chronic Heart Failure (CHF) Health Behavior Heart Diseases Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Civil Hospital Karachi, Dr. Ruth K. M. Pfau Civil Hospital Karachi

Karachi, 74600, Pakistan

Location contact

Muhammad Arshed

CONTACT

[email protected]

03337474464

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Severe psychiatric illness
  • Terminal illness
  • Severe cognitive impairment
  • End-stage renal disease
  • Participation in another intervention trial

Treatment and study plan

RE-AIM-informed autonomy-competence intervention

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Heart Failure (HF)-specific Health-Related Quality of Life (HRQoL)

    Time frame: 3 months

    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.

  2. Implementation outcomes (RE-AIM domains)

    Time frame: 3 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad Arshed, Ph.D.

CONTACT

[email protected]

00923337474464

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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