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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vibeke Lynggaard, Herning Hospital
ClinicalTrials.gov Identifier:
NCT01668394
First received: August 10, 2012
Last updated: December 6, 2016
Last verified: December 2016
  Purpose

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.


Condition Intervention
Rehabilitation Behavioral: Learning and coping arm Other: Control arm

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 Parallel Group Study

Resource links provided by NLM:


Further study details as provided by Vibeke Lynggaard, Herning Hospital:

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

Secondary Outcome Measures:
  • Risk- and lifestyle factors [ Time Frame: 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 ]

Enrollment: 825
Study Start Date: November 2010
Estimated Study Completion Date: December 2017
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Standard cardiac rehabilitation

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 and health related quality of life.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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
Regional Hospital West Jutland
Herning, Central Denmark Region, Denmark, 7400
Sponsors and Collaborators
Herning Hospital
Investigators
Principal Investigator: Vibeke Lynggaard, MHsc Regional Hospital West Jutland
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vibeke Lynggaard, MHsc, PhD student at Cardiovasculat 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: December 6, 2016

ClinicalTrials.gov processed this record on August 16, 2017