Effect of Learning and Coping Strategies in Cardiac Rehabilitation - Group Study (LC-REHAB)

March 9, 2018 updated by: Vibeke Lynggaard, Herning Hospital

Effect of Learning and Coping Strategies in Cardiac Rehabilitation - A Randomised Controlled Parallel Group Study

Background: It is well known that cardiac rehabilitation has potential to reduce morbidity and mortality, but not all patients complete CR. This LC-REHAB trial aims to compare the effect of a new patient education method called learning and coping strategies to that of standard care.

Design: Randomised controlled trial, 1:1 ratio. Participants: Patients above 18 years newly hospitalised with either ischaemic heart disease or heart failure.

Setting: Three hospital Units in Central Denmark Region. Intervention: Cardiac rehabilitation with addition of learning and coping strategies which include participation of experienced patients as co-educators, clarifuing interviews, and inductive teaching style.

Control arm: Standard care cardiac rehabilitation with a decuctive teaching style.

Outcomes: Adherence to cardiac rehabilitation, morbidity, mortality, risk factors, lifestyle, health related quality of life, return to work.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Coronary heart disease is one the most common cause of death in Denmark and is also a chronic disease that 300,000 people in the country are living with. Cardiac rehabilitation is of great significance for this group of people because of its potential to reduce mortality and morbidity. However, not all patients succeed in changing their lifestyle in a positive and heart healthy direction. Thus, it is a great challenge to develop new methods which can help the patients to maintain a more healthy lifestyle in the long run. A concept for patient education, called learning and coping, has been developed in Norway. It is a health education method based on a high degree of involvement from the participants and on what is important for them. Planning, performance and evaluation happens in close cooperation between the health staff and so-called experienced patients. The course begins and ends with individual clarifying interviews.

The aim of this study is to evaluate the effect of learning and coping strategies in cardiac rehabilitation on adherence, risk factors and lifestyle, morbidity and mortality, health related quality of life and return to work.

The number of participants needed are estimated to 750 ptt.s with datacollection at baseline, just after rehabilitation, 3 months after rehabilitation and 3 years after rehabilitation. It is carried out as an open randomised controlled parallel group study in three hospitals in Hospital Unit West Jutland, Central Denmark Region, where the participants newly hospitalised with either ischemic heart disease or heart failure is randomised to either the intervention group with learning and coping strategies or to the standard group without the strategies. The rehabilitation courses in both groups last for eight weeks and consist of both training and education sessions. The concept of learning and coping is applied to the intervention group by letting 'experienced patients' participate in the education and not using standardised teaching slides. Also clarifying individual interviews are completed before and after the course. The 1:1 randomisation is computer generated and is stratified by hospital unit, diagnosis and gender. All analyses will be performed after the principle of 'intention to treat'.

The primary outcomes are adherence to cardiac rehabilitation, morbidity and mortality, while secondary outcomes are risk factors (blood pressure and lipid profile), lifestyle (body mass index, waist circumference, smoking status, exercise capacity and body compositions measured via DXA-scans) and health related quality of life (SF-12, Health Education Impact Questionnaire and Major Depression Inventory) and return to work (derived from the Danish Register for Evaluation of Marginalisation, (DREAM))

Study Type

Interventional

Enrollment (Actual)

825

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Central Denmark Region
      • Herning, Central Denmark Region, Denmark, 7400
        • Regional Hospital West Jutland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients above 18 years hospitalised with ichemic heart disease or heart failure motivated for completing a rehabilitation course

Exclusion Criteria:

  • acute coronary syndrome less than five days before randomisation,
  • active peri-, myo- or endocarditis,
  • untreated symptomatic valvular disease,
  • hypertension with systolic pressure over 200 mmHg and/or diastolic pressure over 110 mmHg,
  • other extracardiac disease,
  • planned revascularization,
  • senile dementia,
  • known compliance and former participation in the study.

Exclusion Criteria for outcome on return to work:

  • age above 60 years
  • recieving public transfer payments related to permanent work incapacity at week of inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Learning and coping arm
Participation of experienced patients as co-educators. Completion of two individual clarifying interviews. Teaching style: situated, reflective, inductive.
Behavioral: Learning and coping arm
Participation of experienced patients as co-educators. Completion of two individual clarifying interviews. Teaching style: situated, reflective, inductive.
Other Names:
  • Learning and coping strategies in cardiac rehabilitation
Placebo Comparator: Control arm
Usual care. Teaching style: deductive.
Other: Control arm
Usual care. Teaching style: deductive.
Other Names:
  • Standard cardiac rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adherence to cardiac rehabilitation
Time Frame: After 8 weeks of cardiac rehabilitation
After 8 weeks of cardiac rehabilitation
Morbidity and mortality
Time Frame: Three or four years after last patient into trial
Three or four years after last patient into trial

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk- and lifestyle factors
Time Frame: At baseline, after 8 weeks of rehabilitation, at 3 months after rehabilitation and at 3 years after rehabilitation
At baseline, after 8 weeks of rehabilitation, at 3 months after rehabilitation and at 3 years after rehabilitation
Health related Quality of life
Time Frame: At baseline, after 8 weeks of rehabilitation, at 3 months after rehabilitation and at 3 years after rehabilitation
At baseline, after 8 weeks of rehabilitation, at 3 months after rehabilitation and at 3 years after rehabilitation
Return to work
Time Frame: at baseline and after one year
Four weeks of self support at follow up derived from the Danish Register for Evaluation of Marginalisation (DREAM)
at baseline and after one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herning Hospital

Investigators

  • Principal Investigator: Vibeke Lynggaard, MHsc, Regional Hospital West Jutland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2010

Primary Completion (Actual)

May 31, 2016

Study Completion (Actual)

March 8, 2018

Study Registration Dates

First Submitted

August 10, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (Estimate)

August 20, 2012

Study Record Updates

Last Update Posted (Actual)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Ethics app. number: 20100230

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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