Clinical trial NCT02463903: Coping Effectiveness Training in Patients With Chronic Heart Failure
Official title: Coping Effectiveness Training in Patients With Chronic Heart Failure - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Adaptation, Psychological
Heart Failure
Intervention Studies
Quality of Life
Hospital Readmission
Depression
Anxiety
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Swedish Red Cross University College
First posted: 2015-06-04
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 (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.

Eligibility criteria: 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.

Primary outcomes:
measure: Emotional well-being (Composite measure of positive and negative affect)
timeFrame: Change from baseline to directly after, 6 weeks, 6 months and 1 year after intervention
measure: Depression and anxiety (Composite measure)
timeFrame: Change from baseline to directly after, 6 weeks, 6 months and 1 year after intervention
Secondary outcomes:
measure: Health-related quality of life (Composite measure)
timeFrame: Change from baseline directly after, 6 weeks, 6 months and 1 year after intervention
Other outcomes:
measure: Readmission to hospital
timeFrame: 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.
Locations:
Study officials:
affiliation: Swedish Red Cross University College
name: Fredrik Saboonchi, Professor
role: STUDY_DIRECTOR
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