Cardiac Rehabilitation: From Hospital to Municipal Setting.

NCT03734185 | Completed DMC

• 1 other identifier: Cardiac Rehab
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 1

Brief Summary

In recent decades, local healthcare services have undergone dramatic changes. The World Health Organization (WHO) refers to a shift from specialized hospital to local healthcare services to meet the growing expectations for better performance and outcomes in health care and better value for money. It is unique that Central Denmark Region has assigned phase II cardiac rehabilitation (CR) as a local healthcare task. However, there is sparse knowledge about how this reform may influence processes of care and outcomes in CR. This association is important to investigate when dramatic organisational changes in settings of evidence based interventions is implemented, as well as in relation to helping people with heart disease return to an active and satisfying everyday life.

Conditions

Cardiac Rehabilitation

Keywords

Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Adherence

  Adherence to CR, defined as percentage of total prescribed sessions.

  During a 12 week programme

Secondary Outcomes (6)

• Health-related quality of life

  4 times during 12 months after engaging Cardia Rehabilitation

• Anxiety and depression

  4 times during 12 months after engaging Cardia Rehabilitation

• Coping

  4 times during 12 months after engaging Cardia Rehabilitation

• Return to work

  12 months after ended Cardiac Rehabilitation

• Cost-effectiveness

  When patients enter intervention CR or usual CR and again 12 months after ended CR

Study Arms (2)

Learning and Coping

EXPERIMENTAL

A health pedagogical strategy that builds on inductive teaching with high involvement of the participants. Characteristics of Learning and Coping are that 'experienced patients' plan, teach and evaluate, in cooperation with health professionals.

Other: Learning and Coping

Usual Cardiac Rehabilitation

ACTIVE COMPARATOR

The theoretical frameworks used in some of these local healthcare services are empowerment, self-efficacy and self-management

Other: Learning and Coping

Interventions

Learning and Coping OTHER

'Experienced patients' plan, teach and evaluate, in cooperation with health professionals.

Learning and Coping; Usual Cardiac Rehabilitation

Eligibility Criteria

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

You may qualify if:

• We include all adult patients ( \>18 years old) discharged from hospital with in Central Denmark Region between September 1, 2018 and July 31, 2019. Ischaemic Heart Disease will be defined according to the International Classification of Diseases version 10 (ICD-10): DI210, DI210A, DI210B, DI211, DI211A, DI211B, DI213, DI214, DI219, DI248, DI249, DI240, DI209, DI251, DI251B, and DI251. In 2016, this population represented approx. 2,700 patients.

You may not qualify if:

• People survive cardiac arrest

Sponsors & Collaborators

• Defactum, Central Denmark Region: lead

Study Sites (1)

Charlotte Gjørup Pedersen

Aarhus, 8000, Denmark

Location

MeSH Terms

Interventions

Educational Status; Coping Skills

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Charlotte Gjørup Pedersen, PhD

  Defactum, Central Denmark Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Included municipalities are expected to receive 2,310 patients with IHD per year (figures from 2017) to attend a CR program. Statistical power; These figures were used to address "the difference in patient outcome in intervention CR and usual CR". Using the minimally important difference available for HeartQoL (mean difference of 2.0, standard deviation 2.0)(1) and the HADS (mean difference of 2.0 and standard deviation of 3.8)(2) and within site clustering ( intra-cluster correlation of 0.01 and an average cluster size of 185 patients - design effect of 2.84) we would need to recruit at least 312 patients per group at 90% power and 5%. References 1. Smid DE, et al. Responsiveness and MCID Estimates for CAT... J Am Med Dir Assoc 2017 Jan;18(1):53-58. 2. Oldridge N, et al. The HeartQoL: Part II. Validation of a new core health-related quality of life questionnaire... Eur J Prev Cardiolog 2014 01/01; 2017/09;21(1):98-106.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: November 7, 2018
• Study Start: September 1, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2022
• Last Updated: July 9, 2025

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)