Ignite Creation Date:
2024-05-06 @ 12:48 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01668394
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2012-08-10
Brief Title:
Effect of Learning and Coping Strategies in Cardiac Rehabilitation - Group Study
Sponsor:
Herning Hospital
Organization:
Herning Hospital
Study Overview
Official Title:
Effect of Learning and Coping Strategies in Cardiac Rehabilitation - A Randomised Controlled Parallel Group Study
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LC-REHAB
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 11 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
Design Randomised controlled trial 11 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
Detailed Description:
Coronary heart disease is one the most common cause of death in Denmark and is also a chronic disease that 300000 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 ptts 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 11 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
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 ptts 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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None