Ignite Creation Date:
2024-05-06 @ 7:06 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02463903
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2015-03-13
Brief Title:
Coping Effectiveness Training in Patients With Chronic Heart Failure
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Coping Effectiveness Training in Patients With Chronic Heart Failure - a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2015-06
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:
None
Brief Summary:
The purpose of the present study is to develop implement and evaluate a stress management program aiming to improve emotional well-being health-related quality of life and to reduce readmission to hospital in patients with chronic heart failure CHF
Method A randomized controlled study design will be employed in which the intervention consists of Coping Effectiveness Training CET a manual-based group intervention based on a cognitive transactional theory of stress and coping The purpose of CET is to improve skills to appraise stress teach a number of techniques to cope with stress and to give an opportunity to interact with other people with similar experiences of living with CHF The control group will receive standard health care The intervention group will receive seven weekly sessions of CET Self-assessments of emotional well-being depression and anxiety illness perception health-related quality of life coping strategies and social support will be performed before the intervention directly after the intervention six weeks six months and one year after the intervention period as well as measuring readmission to hospital In addition the participants in the intervention group will fill in an anonymous written evaluation with closed and open ended questions directly after the intervention
Method A randomized controlled study design will be employed in which the intervention consists of Coping Effectiveness Training CET a manual-based group intervention based on a cognitive transactional theory of stress and coping The purpose of CET is to improve skills to appraise stress teach a number of techniques to cope with stress and to give an opportunity to interact with other people with similar experiences of living with CHF The control group will receive standard health care The intervention group will receive seven weekly sessions of CET Self-assessments of emotional well-being depression and anxiety illness perception health-related quality of life coping strategies and social support will be performed before the intervention directly after the intervention six weeks six months and one year after the intervention period as well as measuring readmission to hospital In addition the participants in the intervention group will fill in an anonymous written evaluation with closed and open ended questions directly after the intervention
Detailed Description:
Aim To develop implement and evaluate a stress management program in form of patient education to improve stress management and emotional well-being health-related quality of life as well as readmission to hospital in patients with chronic heart failure CHF
Hypothesis It is hypothesised that a Coping Effectiveness Training CET stress management program adapted for CHF improves stress management and emotional well-being primary endpoint health-related quality of life secondary endpoint and reduces readmission to hospital tertiary endpoint in patient with CHF
Method A randomized controlled study design will be employed in which the intervention consists of patient education Coping Effectiveness Training CET CET is a manual based group intervention which is based on the cognitive transactional theory of stress and coping The CET programme will in this study be adjusted and modified to patients with CHF
The control group n45 will receive standard health care The intervention group n45 will receive CET intervention in form of patient education led by a nurse with a master degree in nursing science and extensive experience in heart failure care The intervention will consist of seven 90-minute weekly sessions Each group will consist of 8 to 12 patients
Measurements of the included variables will be performed before the intervention directly after the intervention six weeks six months and one year after the intervention period The following instruments will be employed for measuring outcome variables PANAS for measuring emotional well-being HADS for measuring depression and anxiety B-IPQ for measuring the patients appraisal and cognitive representation of of living with CHF RAND-36 for measuring quality of life Brief COPE for measuring coping strategies and thereby stress management and ESSI for measuring social support Clinical variables that will be included are readmission to hospital and NYHA-class
Data collection will be held at Danderyd Hospital The inclusion criteria is patients diagnosed with CHF hospitalized at a heart failure ward or a heart failure outpatient clinic in Stockholm County Council Sweden are classified in NYHA-class II-III and are aged over 18 years Exclusion criteria are cognitive dysfunction life threatening disease such as cancer or primary organ failure andor severe psychiatric diagnosis such as psychosis or severe depression and not being able to understand the Swedish language
Statistical analysis A preliminary power analysis with a moderate effect size of Cohens d 050 and alpha 005 indicates that to obtain a power of 080 a sample size of 90 patients n45 for each group is needed Cohen 1988 MANOVA for repeated measurements for evaluating the intervention effect
Readmissionhealth care consumption will be measured by
1 Time to first readmission cardiovascular readmission or cardiovascular death
2 Time to first readmission all cause or death despite cause
3 Total time for inpatient care Primary analysis will be conducted through MANCOVAS for repeated measures Survival analysis Kaplan Meyer and Cox regressions analysis will be conducted for assessing the effect on readmissions to hospital
Hypothesis It is hypothesised that a Coping Effectiveness Training CET stress management program adapted for CHF improves stress management and emotional well-being primary endpoint health-related quality of life secondary endpoint and reduces readmission to hospital tertiary endpoint in patient with CHF
Method A randomized controlled study design will be employed in which the intervention consists of patient education Coping Effectiveness Training CET CET is a manual based group intervention which is based on the cognitive transactional theory of stress and coping The CET programme will in this study be adjusted and modified to patients with CHF
The control group n45 will receive standard health care The intervention group n45 will receive CET intervention in form of patient education led by a nurse with a master degree in nursing science and extensive experience in heart failure care The intervention will consist of seven 90-minute weekly sessions Each group will consist of 8 to 12 patients
Measurements of the included variables will be performed before the intervention directly after the intervention six weeks six months and one year after the intervention period The following instruments will be employed for measuring outcome variables PANAS for measuring emotional well-being HADS for measuring depression and anxiety B-IPQ for measuring the patients appraisal and cognitive representation of of living with CHF RAND-36 for measuring quality of life Brief COPE for measuring coping strategies and thereby stress management and ESSI for measuring social support Clinical variables that will be included are readmission to hospital and NYHA-class
Data collection will be held at Danderyd Hospital The inclusion criteria is patients diagnosed with CHF hospitalized at a heart failure ward or a heart failure outpatient clinic in Stockholm County Council Sweden are classified in NYHA-class II-III and are aged over 18 years Exclusion criteria are cognitive dysfunction life threatening disease such as cancer or primary organ failure andor severe psychiatric diagnosis such as psychosis or severe depression and not being able to understand the Swedish language
Statistical analysis A preliminary power analysis with a moderate effect size of Cohens d 050 and alpha 005 indicates that to obtain a power of 080 a sample size of 90 patients n45 for each group is needed Cohen 1988 MANOVA for repeated measurements for evaluating the intervention effect
Readmissionhealth care consumption will be measured by
1 Time to first readmission cardiovascular readmission or cardiovascular death
2 Time to first readmission all cause or death despite cause
3 Total time for inpatient care Primary analysis will be conducted through MANCOVAS for repeated measures Survival analysis Kaplan Meyer and Cox regressions analysis will be conducted for assessing the effect on readmissions to hospital
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