Heart Rehabilitation for All

NCT05104658 | Active Not Recruiting

• 1 other identifier: 19-R136-A9125-22129
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

Today, 50 % of cardiac patients do not participate in cardiac rehabilitation due difficulties in navigating and accessing rehabilitation activities. HeRTA is a partnership project involving Center for Clinical Research and Prevention (CCRP), Hvidovre Hospital, Rehabilitation Center Albertslund and Copenhagen (municipalities), the Danish Heart Association, and local sports associations. A patient advisory board participate throughout the project to ensure a continued focus on patient interests. The overall aim of HeRTA is to develop and test the feasibility of a new, sustainable model for rehabilitation supporting patients to take part in rehabilitation and promoting life-long activity for all patients with heart disease. To ensure equal access to rehabilitation some activities are open to all patients, while others are tailored specifically to patients with vulnerability. The project unfolds in three phases: Development (1. January 1. 2020 - 14. November 2021): Partners and patients co-create content and procedures; Feasibility (15. November 2021 - 31. July 2023): The feasibility of the model is tested, and promising components are identified; Long-term follow-up and implementation (1. August 2023 - 31. December 2025): Long term effects are investigated and promising components are tested in new settings. During the feasibility phase the investigators will examine whether the intervention activities are feasible, acceptable, and may have positive effects for patients with heart disease. The investigators use qualitative data on implementation and acceptability of intervention among partners and patients. An randomisered controlled trial (RCT) component will assess effects on patient participation rates, health, physical activity level, and life quality. Data is collected from practitioners and patients through focus groups, observations, field notes, questionnaires, and interviews. Results will point to:

• innovative ways to organize integrated rehabilitation pathways.
• approaches to ensuring rehabilitation targeted at patient needs.

Conditions

Ischemic Heart Disease; Cardiac Valve Surgery; Persistent Atrial Fibrillation; Heart Failure

Keywords

Heart disease; Heart rehabilitation

Outcome Measures

Primary Outcomes (1)

• Participation in rehabilitation

  The study's primary outcome is participation defined in three graduated participation levels: 1. attending ≥ one activity (proactive counseling, patient education, smoking cessation, dietary counseling, physical exercise, local sports association activity). 2. attending ≥ two activities (proactive counseling, patient education, smoking cessation, dietary counseling, physical exercise, local sports association activity). 3. attending ≥ two activities (proactive counseling, patient education, smoking cessation, dietary counseling, physical exercise, local sports association activity) and reaching at least 50% turn up

  Up to 20 months and two weeks

Secondary Outcomes (4)

• Sustained physical activity in leisure time

  Up to 44 months + two weeks

• Health-related quality of life

  Up to 44 months + two weeks

• Patient involvement

  Up to 20 months and two weeks

• Location and setting for physical activity

  Up to 44 months and two weeks

Study Arms (2)

Intervention arm

EXPERIMENTAL

Usual rehabilitation: training (1 hour 2 times a week for 6 weeks), dietary training (2x3 hours), cardiac education (2x3 hours), referred to municipal rehabilitation: training (1 hour 2 times a week for 6-12 weeks), patient education (3x2 hours by a cardiac nurse and 1x2 hours by a dietician). In addition: * Information book on rehabilitation and physical activities in local community * 1:1 conversation with patient supporters from the Heart Association * Employer material on post-treatment and potential work adjustments * Support café for relatives * Supported transition to local sports associations * Motivating phone calls from physiotherapists supporting physical activities. In addition for patients with vulnerabilities: * patient education in small groups * pro-active counselling with a cardiac nurse, a psychologist, or a social worker from the Heart Association * paid transportation to the municipal rehabilitation Center

Other: Patient-targeted rehabilitation offers

Control arm

NO INTERVENTION

Usual rehabilitation: training (1 hour 2 times a week for 6 weeks), dietary training (2x3 hours), cardiac education (2x3 hours), referred to municipal rehabilitation: training (1 hour 2 times a week for 6-12 weeks), patient education (3x2 hours by a cardiac nurse and 1x2 hours by a dietician).

Interventions

Patient-targeted rehabilitation offers OTHER

In addition to usual rehabilitation services, patients in the intervention arm will receive patient-targeted rehabilitation offers to support the patients' participation and completion of their heart rehabilitation course.

Intervention arm

Eligibility Criteria

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

You may qualify if:

• Diagnosed with ischaemic heart disease, cardiac valve surgery, persistent atrial fibrillation, or heart failure
• Resident in Hvidovre Hospitals uptake area
• Cognitively functional
• Physically able to participate in rehabilitation activities

Sponsors & Collaborators

• Center for Clinical Research and Prevention: lead
• Danish Heart Foundation: collaborator
• Hvidovre University Hospital: collaborator
• Albertslund Municipality: collaborator

Study Sites (1)

Center for Clinical Research and Prevention

Frederiksberg, Copenhagen, 2000, Denmark

Location

Related Publications (1)

• Birke H, Foxvig I, Burns K, Toft U, Hansen ABG, Hauge PI, Foghmar S, Mindegaard RB, Jakobsen LM. Heart Rehabilitation for All (HeRTA): Protocol for a feasibility study and pilot randomized trial. PLoS One. 2022 Jun 17;17(6):e0270159. doi: 10.1371/journal.pone.0270159. eCollection 2022.

  PMID: 35714121 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia; Atrial Fibrillation; Heart Failure; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hanne Birke, Ph.D.

  Center for Clinical Research and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not possible as the primary outcome is participation in rehabilitation activities. However, health professionals at the hospital are allocated to either intervention or control group, to minimise cross-contamination.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: The participants will be block randomised according to vulnerability to either the intervention or the control study arm

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: November 3, 2021
• Study Start: April 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)