Coping Effectiveness Training in Patients With Chronic Heart Failure

Heart Failure Clinical Trial

Official title:

Coping Effectiveness Training in Patients With Chronic Heart Failure - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02463903
• Other study ID #: 20140001
• Status: Completed
• Phase: N/A
• First received: March 13, 2015
• Last updated: June 4, 2015
• Start date: March 2011
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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 (n=45) will receive standard health care. The intervention group (n=45) 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 and/or 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 Cohen`s d = 0.50 and alpha = 0.05 indicates that to obtain a power of 0.80 a sample size of 90 patients (n=45 for each group) is needed (Cohen, 1988). MANOVA for repeated measurements for evaluating the intervention effect.

Readmission/health 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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:

• Cognitive dysfunction

• life threatening disease such as cancer or primary organ failure and/or severe psychiatric diagnosis such as psychosis or severe depression, and

• not being able to understand the Swedish language.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Coping Effectiveness Training (CET)
The participants in the intervention group will receive a work book explaining the theme and home assignment as well as providing a brief summary of every group session. The group leader has a manual. Both work book and manual have been translated to Swedish and adjusted to patients with chronic heart failure.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Swedish Red Cross University College

References & Publications (8)

Berkman LF, Blumenthal J, Burg M, Carney RM, Catellier D, Cowan MJ, Czajkowski SM, DeBusk R, Hosking J, Jaffe A, Kaufmann PG, Mitchell P, Norman J, Powell LH, Raczynski JM, Schneiderman N; Enhancing Recovery in Coronary Heart Disease Patients Investigators (ENRICHD). Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial. JAMA. 2003 Jun 18;289(23):3106-16. — View Citation

Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. — View Citation

Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. — View Citation

Chesney MA, Folkman S. Psychological impact of HIV disease and implications for intervention. Psychiatr Clin North Am. 1994 Mar;17(1):163-82. Review. — View Citation

Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. — View Citation

Lazarus, R.S., & Folkman, S. (1984). Stress, appraisal and coping. New York: Springer Publishing Company.

Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Readmission to hospital	Time to first readmission cardiovascular readmission or cardiovascular death.; Time to first readmission all cause or death despite cause.; Total time for inpatient care.	During the entire follow-up period, mean follow-up time an average of 3 years (median) but at least 1 year. From start of the first intervention group to end of study-date.	No
Primary	Emotional well-being (Composite measure of positive and negative affect)	As measured by self-assessment questionnaire PANAS. Analysis will be conducted with Repeated measures ANCOVA.	Change from baseline to directly after, 6 weeks, 6 months and 1 year after intervention	No
Primary	Depression and anxiety (Composite measure)	As measured by self-assessment questionnaire HADS. Analysis will be conducted with Repeated measures ANCOVA.	Change from baseline to directly after, 6 weeks, 6 months and 1 year after intervention	No
Secondary	Health-related quality of life (Composite measure)	As measured by self-assessment questionnaire RAND 36. Analysis will be conducted with Repeated measures ANCOVA.	Change from baseline directly after, 6 weeks, 6 months and 1 year after intervention	No