Heart FailureNCT02463903
Coping Effectiveness Training in Patients With Chronic Heart Failure
A study testing Coping Effectiveness Training (CET) in people with Heart Failure, run by Karolinska Institutet.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Coping Effectiveness Training (CET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Coping Effectiveness Training in Patients With Chronic Heart Failure - a Randomized Controlled Trial
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.
Read the 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:
- Time to first readmission cardiovascular readmission or cardiovascular death.
- Time to first readmission all cause or death despite cause.
- 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.
- Conditions
- Heart Failure
- Being tested
- Coping Effectiveness Training (CET)
- Keywords
- Adaptation, Psychological, Heart Failure, Intervention Studies, Quality of Life, Hospital Readmission, Depression, Anxiety
- Medical subject headings
- Heart Failure, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping Effectiveness Training (CET)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Coping effectiveness Training (CET) | Experimental | 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 CET program will, in this study, be modified for patients with CHF. The intervention consists of seven, 90-minute weekly sessions led by a nurse with a Masters degree in nursing science and extensive experience in heart failure care in collaboration with a professional psychologist. Each group consisted of 8 to 12 patients. Receives: Behavioral: Coping Effectiveness Training (CET) |
| Control | No intervention | The control group will receive standard health care and will not take part of the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to directly after, 6 weeks, 6 months and 1 year after intervention
Depression and anxiety (Composite measure)
As measured by self-assessment questionnaire HADS. Analysis will be conducted with Repeated measures ANCOVA.
Measured: Change from baseline to directly after, 6 weeks, 6 months and 1 year after intervention
Secondary outcomes (1)
Health-related quality of life (Composite measure)
As measured by self-assessment questionnaire RAND 36. Analysis will be conducted with Repeated measures ANCOVA.
Measured: Change from baseline directly after, 6 weeks, 6 months and 1 year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startMar 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Red Cross University College
- Responsible party
- Principal investigator, Fredrik Saboonchi, Karolinska Institutet
- Investigators
- Fredrik Saboonchi, Professor, Study director, Swedish Red Cross University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463903
- Sponsor's protocol ID
- 20140001
- Status last verified
- Jun 2015
- First submitted
- 13 Mar 2015
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Carver 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. doi: 10.1207/s15327558ijbm0401_6.
PubMed 16250744Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
PubMed 16731240Berkman 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. doi: 10.1001/jama.289.23.3106.
PubMed 12813116Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305.
PubMed 8275167Chesney MA, Folkman S. Psychological impact of HIV disease and implications for intervention. Psychiatr Clin North Am. 1994 Mar;17(1):163-82.
PubMed 8190663Lazarus, R.S., & Folkman, S. (1984). Stress, appraisal and coping. New York: Springer Publishing Company.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping Effectiveness Training in Patients With Chronic Heart Failure - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02463903
- Acronym / sponsor ID
- 20140001
- Conditions
- Heart Failure
- Keywords
- Adaptation, Psychological, Heart Failure, Intervention Studies, Quality of Life, Hospital Readmission, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Swedish Red Cross University College
- Study start
- Mar 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Time to first readmission cardiovascular readmission or cardiovascular death.
- Time to first readmission all cause or death despite cause.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coping effectiveness Training (CET) | Experimental | Behavioral: Coping Effectiveness Training (CET)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 CET program will, in this study, be modified for patients with CHF. The intervention consists of seven, 90-minute weekly sessions led by a nurse with a Masters degree in nursing science and extensive experience in heart failure care in collaboration with a professional psychologist. Each group consisted of 8 to 12 patients. |
| Control | No intervention | –The control group will receive standard health care and will not take part of the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Coping effectiveness Training (CET) |
Primary outcome
Emotional well-being (Composite measure of positive and negative affect)
Time frame: Change from baseline to directly after, 6 weeks, 6 months and 1 year after intervention
As measured by self-assessment questionnaire PANAS. Analysis will be conducted with Repeated measures ANCOVA.
Depression and anxiety (Composite measure)
Time frame: Change from baseline to directly after, 6 weeks, 6 months and 1 year after intervention
As measured by self-assessment questionnaire HADS. Analysis will be conducted with Repeated measures ANCOVA.
1 secondary outcome
Health-related quality of life (Composite measure)
Time frame: Change from baseline directly after, 6 weeks, 6 months and 1 year after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- Background: PubMed 3397865Watson 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. doi: 10.1037//0022-3514.54.6.1063.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Background: PubMed 16250744Carver 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. doi: 10.1207/s15327558ijbm0401_6.
- Background: PubMed 16731240Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
- Background: PubMed 12813116Berkman 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. doi: 10.1001/jama.289.23.3106.
- Background: PubMed 8275167Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305.
- Background: PubMed 8190663Chesney MA, Folkman S. Psychological impact of HIV disease and implications for intervention. Psychiatr Clin North Am. 1994 Mar;17(1):163-82.
- BackgroundLazarus, R.S., & Folkman, S. (1984). Stress, appraisal and coping. New York: Springer Publishing Company.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredrik Saboonchi, Professor study director
Swedish Red Cross University College
Questions about this trial
What is this clinical trial studying?
A study testing Coping Effectiveness Training (CET) in people with Heart Failure, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional well-being (Composite measure of positive and negative affect) (time frame: Change from baseline to directly after, 6 weeks, 6 months and 1 year after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02463903, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.