Cost-effectiveness of a RE-AIM-Informed Autonomy-Competence Intervention to Improve Medication Adherence and Quality of Life Among Patients With Heart Failure

NCT07580508 | Not Yet Recruiting DMC

• 1 other identifier: BMUUU
• Study Type: interventional
• Target: 870
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Heart Failure; Chronic Heart Failure (CHF)

Keywords

Chronic Heart Failure; Medication adherence; Cost-effectiveness; Randomized controlled trial; RE-AIM

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 months

Secondary Outcomes (2)

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

  3 months

• Implementation outcomes (RE-AIM domains)

  3 months

Study Arms (2)

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.

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

Interventions

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

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

Karachi, 74600, Pakistan

Location

MeSH Terms

Conditions

Heart Failure; Medication Adherence

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Muhammad Arshed, Ph.D.

CONTACT

00923337474464; drarshedchaudhary@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and outcome assessors will remain blind regarding group allocation
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: It will be a two-arm randomized controlled trial

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 12, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): August 24, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)