Effect of Learning and Coping Strategies in Cardiac Rehabilitation - Group Study

NCT01668394 | Completed

• 1 other identifier: Ethics app. number: 20100230
• Study Type: interventional
• Target: 825
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Adherence to cardiac rehabilitation

  After 8 weeks of cardiac rehabilitation

• Morbidity and mortality

  Three or four years after last patient into trial

Secondary Outcomes (3)

• Risk- and lifestyle factors

  At baseline, after 8 weeks of rehabilitation, at 3 months after rehabilitation and at 3 years after rehabilitation

• Health related Quality of life

  At baseline, after 8 weeks of rehabilitation, at 3 months after rehabilitation and at 3 years after rehabilitation

• Return to work

  at baseline and after one year

Study Arms (2)

Learning and coping arm

ACTIVE COMPARATOR

Participation of experienced patients as co-educators. Completion of two individual clarifying interviews. Teaching style: situated, reflective, inductive.

Behavioral: Learning and coping arm

Control arm

PLACEBO COMPARATOR

Usual care. Teaching style: deductive.

Other: Control arm

Interventions

Learning and coping arm BEHAVIORAL

Participation of experienced patients as co-educators. Completion of two individual clarifying interviews. Teaching style: situated, reflective, inductive.

Also known as: Learning and coping strategies in cardiac rehabilitation

Learning and coping arm

Control arm OTHER

Usual care. Teaching style: deductive.

Also known as: Standard cardiac rehabilitation

Control arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.
• age above 60 years

Sponsors & Collaborators

• Herning Hospital: lead

Study Sites (1)

Regional Hospital West Jutland

Herning, Central Jutland, 7400, Denmark

Location

Related Publications (4)

• Lynggaard V, May O, Beauchamp A, Nielsen CV, Wittrup I. LC-REHAB: randomised trial assessing the effect of a new patient education method--learning and coping strategies--in cardiac rehabilitation. BMC Cardiovasc Disord. 2014 Dec 13;14:186. doi: 10.1186/1471-2261-14-186.

  PMID: 25495543 BACKGROUND

• Bitsch BL, Nielsen CV, Stapelfeldt CM, Lynggaard V. Effect of the patient education - Learning and Coping strategies - in cardiac rehabilitation on return to work at one year: a randomised controlled trial show (LC-REHAB). BMC Cardiovasc Disord. 2018 May 21;18(1):101. doi: 10.1186/s12872-018-0832-2.

  PMID: 29783942 DERIVED

• Lynggaard V, Nielsen CV, Zwisler AD, Taylor RS, May O. The patient education - Learning and Coping Strategies - improves adherence in cardiac rehabilitation (LC-REHAB): A randomised controlled trial. Int J Cardiol. 2017 Jun 1;236:65-70. doi: 10.1016/j.ijcard.2017.02.051. Epub 2017 Feb 21.

  PMID: 28259552 DERIVED

• Dehbarez NT, Lynggaard V, May O, Sogaard R. Learning and coping strategies versus standard education in cardiac rehabilitation: a cost-utility analysis alongside a randomised controlled trial. BMC Health Serv Res. 2015 Sep 28;15:422. doi: 10.1186/s12913-015-1072-0.

  PMID: 26412226 DERIVED

Related Links

• BMC Cardiovascular Disorders

MeSH Terms

Interventions

Educational Status; Coping Skills; Cardiac Rehabilitation

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Vibeke Lynggaard, MHsc

  Regional Hospital West Jutland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MHsc, PhD student at Cardiovasculat Research Unit

Study Record Dates

• First Submitted: August 10, 2012
• First Posted: August 20, 2012
• Study Start: November 30, 2010
• Primary Completion: May 31, 2016
• Study Completion: March 8, 2018
• Last Updated: March 12, 2018

Record last verified: 2018-03

Locations

DK (1)