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Does offering a hybrid cardiac rehabilitation programme increase uptake and adherence compared to in-person programmes?

Industrial research to generate evidence for submission to NICE, using a novel, real-world trial design for a technology-enabled, hybrid service for cardiac rehabilitation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12527081
Enrollment
540
Registered
2023-07-03
Start date
2023-06-01
Completion date
Unknown
Last updated
2025-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac rehabilitation in people with cardiovascular disease Circulatory System

Interventions

Active+me is a medical-grade platform, which is cloud-based, with an app that patients can access on their smartphone with Bluetooth or connected medical monitors. It has a fully customisable suite of

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Work package 1 (NACR data): Invited to cardiac rehabilitation. If there are sufficient numbers the sample will be limited to people who have acute coronary syndrome. This will make the sample homogeneous in terms of the index condition. Work package 2 (qualitative): 1. Staff involved in the delivery or management of a cardiac rehabilitation service offering a hybrid programme using Active_me for the remote part of the programme 2. Patients who were offered and/or engaged with a hybrid cardiac rehab programme using Active+me

Exclusion criteria

Exclusion criteria: Work package 1 (NACR data): Does not meet the inclusion criteria Work package 2 (qualitative): 1. Staff not involved in the delivery or management of a cardiac rehabilitation service offering a hybrid programme using Active_me for the remote part of the programme 2. Patients who were not offered the hybrid cardiac rehab programme using Active+me

Design outcomes

Primary

MeasureTime frame
Uptake of cardiac rehabilitation, defined as attending at least one CR session, either in-person or remotely, recorded on the NACR database within 6 months of referral. A session will be defined in accordance with version 1.2 of the BACPR/NACR definition (June 2020).

Secondary

MeasureTime frame
1. Adherence to cardiac rehabilitation will be measured as at least 50% of planned cardiac rehabilitation sessions attended and a completion date recorded within approx. 6 months after programme start 2. Health-related quality of life measured by the Dartmouth CO-OP charts measured at programme start and end (approx. 3 months) 3. Anxiety and depression scores measured by the Hospital Anxiety and Depression Scale, the Generalised Anxiety Disorder Assessment (GAD-7) and Patient Health Questionnaire (PHQ-9) at programme start and end (approx. 3 months) 4. Fitness measured by incremental shuttle walk test or 6-minute walk test at programme start and end (approx. 3 months) 5. Smoking cessation measured using self report at programme start and end (approx. 3 months) 6. Self-report of 150 min physical activity/week at programme end (approx. 3 months)

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026