Effect of Learning and Coping Strategies in Cardiac Rehabilitation - Group Study (LM-REHAB)
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Purpose
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 a lot of people are not succeeding in changing their lifestyle in a positive direction, and 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 conversations.
The aim of this study is to evaluate the effect of the concept of learning and coping strategies in cardiac rehabilitation on quality of life, risc- and lifestyle factors, morbidity and mortality.
The number of participants are estimated to 750 ptt.s with datacollection at baseline, just after rehabilitation and 3 months after rehabilitation. It is carried out as an open randomized controlled parallel group study in three hospitals in Hospitalsenheden Vest, Central Denmark Region, where the participants is randomized to either the intervention group with learning and coping strategies or to the standard group without the strategies. The rehabilitation courses in both groups lasts for eight weeks and consists of both training and educations sessions. The concept of learning and coping is applied to the intervention group by letting 'experienced patients' participate in the education and not using standardized teaching slides. Also clarifying individual conversations are completed before and after the course. The 1:1 randomization is computer generated and is stratified by hospital, diagnosis and gender. All analyses will be performed after the principle of 'intention to treat'.
| Condition | Intervention |
|---|---|
|
Rehabilitation |
Behavioral: Learning and coping strategy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effect of Learning and Coping Strategies in Cardiac Rehabilitation - A Randomised Controlled Parallelgroup Study |
- Quality of life [ Time Frame: At baseline, after 8 weeks of rehabilitation with or without intervention and 3 mths after rehabilitation has been completed ] [ Designated as safety issue: No ]
- Risc and lifestyle factors [ Time Frame: At baseline, after 8 weeks of rehabilitation with or without intervention and 3 mths after rehabilitation has been completed ] [ Designated as safety issue: No ]
- Morbidity and mortality [ Time Frame: At baseline, after 8 weeks of rehabilitation with or without intervention and 3 mths after rehabilitation has been completed ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 750 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rehabilitation with learnings and coping strategies applied
The concept of learning and coping strategies is applied to the intervention group by letting 'experienced patients' participate in the education and not using standardized teaching slides. Also clarifying individual conversations are completed before and after the course.
|
Behavioral: Learning and coping strategy |
| Placebo Comparator: Rehabilitation without learning and copin strategies |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- persons over 18 years with coronary artery disease or heart failure who has been admitted to hospital being 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.
Contacts and Locations| Denmark | |
| Region Hospital Herning | Recruiting |
| Herning, Central Region, Denmark, 7400 | |
| Contact: Vibeke Lynggaard, Master of Health Science +45 78436244 viblyn@rm.dk | |
| Contact: Ole May, MD, Ph.D +45 78436177 ole.may@vest.rm.dk | |
| Principal Investigator: Ole May, MD, Ph.D | |
More Information
No publications provided
| Responsible Party: | Ole May, MD, Ph.D, Head of Cardiology Research Unit, Herning Hospital |
| ClinicalTrials.gov Identifier: | NCT01668394 History of Changes |
| Other Study ID Numbers: | Ethics app. number: 20100230 |
| Study First Received: | August 10, 2012 |
| Last Updated: | August 20, 2012 |
| Health Authority: | Denmark: Ethics Committee |
ClinicalTrials.gov processed this record on May 23, 2013