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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Herning Hospital
Sponsor:
Information provided by (Responsible Party):
Ole May, Herning Hospital
ClinicalTrials.gov Identifier:
NCT01668394
First received: August 10, 2012
Last updated: August 20, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by Herning Hospital:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668394

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         
Sponsors and Collaborators
Herning Hospital
  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 July 31, 2014