Affordable Cardiac Rehabilitation: An Outreach Inter-disciplinary Strategic Study (ACROSS): External Pilot Trial v1

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Coronary heart disease and/or heart failure with co-existing depression and/or anxiety (n=400). Intervention: ACROSS home-based cardiac rehabilitation programme plus usual care vs. Usual care alone (plus a single general information booklet). Primary outcome: Feasibility and progression criteria (recruitment, intervention completion, and trial retention).

Mithila Faruque; Nusrat Husain; Bushra Shah; Rod Taylor; Sehrish Tofique; Zainab Zadeh; Imran Chaudhry; Jamal Uddin; David Innes

doi:10.17504/protocols.io.qpvrexqezlmk/v1

October 12, 2026Open Access

Affordable Cardiac Rehabilitation: An Outreach Inter-disciplinary Strategic Study (ACROSS): External Pilot Trial v1

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Key result

The ACROSS external pilot protocol will randomize 400 patients (2:1) in Bangladesh and Pakistan to evaluate the feasibility of a 12-week culturally adapted home-based cardiac rehabilitation program.

Why the study?

The feasibility, acceptability, and costs of a culturally adapted, home-based cardiac rehabilitation programme for adults with heart disease and co-existing depression and/or anxiety required evaluation.

Does a culturally adapted, home-based cardiac rehabilitation programme (ACROSS) plus usual care demonstrate feasibility and acceptability compared to usual care alone in adults with coronary heart disease or heart failure and co-existing depression and/or anxiety in Bangladesh and Pakistan?

Key Points

To evaluate the feasibility, acceptability, and costs of a culturally adapted, home-based cardiac rehabilitation programme for adults with heart disease and co-existing depression or anxiety.
Conducted an external pilot trial coordinated across delivery sites in Bangladesh and Pakistan.
Assessed progression readiness to a definitive trial using a traffic light stop/go framework (green, amber, red, black) across recruitment, retention, adherence, and fidelity criteria.
Scheduled outcome measurements electronically or in person at baseline (pre-randomisation) and at 4-months post-randomisation using blinded assessors.
Established traffic light progression rules requiring all four core criteria to meet at least an amber rating to proceed to the full-scale trial.
Determined that any red threshold outcome requires a formal action plan submitted to the International Steering Committee, whereas a black outcome prompts strong likelihood of trial discontinuation.

Study Design

Type

RCT (n=400)

Randomization

Individual 2:1 randomization minimized within country by centre, cardiac diagnosis (CHD vs. HF), and sex

Multicenter

Yes

Structured PICO

Does a culturally adapted, home-based cardiac rehabilitation programme (ACROSS) plus usual care demonstrate feasibility and acceptability compared to usual care alone in adults with coronary heart disease or heart failure and co-existing depression and/or anxiety in Bangladesh and Pakistan?

P

Population

Planned recruitment of 400 adults (≥18 years) in Bangladesh and Pakistan hospitalized for coronary heart disease or heart failure (LVEF <45%) with co-existing depression (PHQ-9 ≥5) and/or anxiety (GAD-7 ≥5), excluding those with contraindications to exercise or <12-month prognosis.

I

Intervention

ACROSS programme plus usual care: a culturally adapted, home-based cardiac rehabilitation intervention (based on the Heart Manual for CHD patients and REACH-HF for heart failure patients) delivered over a defined period (12 weeks) via manual/booklet with support from a trained healthcare professional (face-to-face, telephone call, webinar, or app), covering tailored exercise training (walking programme or chair-based exercise DVD), management of depression/anxiety, symptom and risk factor monitoring, and medication management.

C

Comparator

Usual care alone (no structured rehabilitation), supplemented with a single information booklet providing general guidance on heart disease, recovery, and self-management. Both intervention and control groups receive usual medical management for their heart disease and mental health disorder according to national/local guidelines.

O

Outcome

Feasibility and progression criteria (including target sample size/recruitment, retention, and intervention adherence and fidelity) assessed using a traffic light stop/go system, alongside feasibility of collecting participant-reported outcomes at 4 months post-randomisation.

This study protocol outlines an external pilot randomized trial to evaluate the feasibility, acceptability, and cost drivers of a culturally adapted, home-based cardiac rehabilitation program for patients with heart disease and comorbid depression or anxiety in Bangladesh and Pakistan.

Limitations

Study protocol only; no trial results or clinical outcomes are reported yet
External pilot trial designed to assess feasibility and progression criteria rather than definitive clinical effectiveness

Ask about this paper

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Implication

Pilot feasibility testing of culturally adapted home-based CR in South Asia; leaves open scalability and outcomes before any practice change.

Abstract

The ACROSS study evaluates the feasibility, acceptability, and costs of a culturally adapted, home-based cardiac rehabilitation programme for adults with heart disease and co-existing depression and/or anxiety.

Discussion

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Cite This Study

Faruque et al. (2026) conducted an RCT in Coronary heart disease and/or heart failure with co-existing depression and/or anxiety (n=400). ACROSS home-based cardiac rehabilitation programme plus usual care vs. Usual care alone (plus a single general information booklet) was evaluated on Feasibility and progression criteria (recruitment, intervention completion, and trial retention). The ACROSS external pilot protocol will randomize 400 patients (2:1) in Bangladesh and Pakistan to evaluate the feasibility of a 12-week culturally adapted home-based cardiac rehabilitation program.

synapsesocial.com/papers/6ae682a3e432e7a5c4ef3662 https://doi.org/10.17504/protocols.io.qpvrexqezlmk/v1

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Affordable Cardiac Rehabilitation: An Outreach Inter-disciplinary Strategic Study (ACROSS): External Pilot Trial v1

Key Points

Study Design

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Affordable Cardiac Rehabilitation: An Outreach Inter-disciplinary Strategic Study (ACROSS): External Pilot Trial v1

Key Points

Study Design

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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