REmote Web Assisted Care for Heart Failure Patients With Implantable Cardioverter Defibrillators

Study Overview
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Brief Summary
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Aim and Background: Although implantable cardioverter defibrillators (ICD) save lives, many ICD-patients experience psychosocial complications such as anxiety disorders, depression and reduced quality of life after ICD-implantation. A recent review has indicated great potential for psychosocial interventions to reduce anxiety and to increase exercise capacity of ICD-patients. In a previous study, the investigators showed that mailed information about technical, medical and psychological effects of ICD plus phone counseling are effective interventions for reducing anxiety, psychological distress and increasing QoL in ICD-patients < 65 years. In a pilot study the investigators also documented promising effects of an internet based intervention with similar content. Method: In a prospective, multicenter, multidisciplinary, half-open, part-randomized, controlled clinical trial N = 200 patients with an ICD will either receive medical care as usual or additionally attend a psychosocial prevention program via remote care. Psychosocial support will be provided utilizing the advantages of the internet. Thus, patient-centered support will be offered independent from time and location. Outcome measures are psychometric data (questionnaires on cardiac fear, etc.), cardiac functioning, and clinical status which will be assessed up to 1 week before ICD-implantation (T0), in week 1 (T1) and within one week after (T2) the 6-weeks prevention program, and 12 months after T0 (T3). Furthermore, demographic data, personality characteristics, expectations, physiology, pro-inflammatory cytokines and cardiac status will be assessed as mediating or moderating variables. Hypotheses: A web-based psychosocial intervention in addition to medical care as usual leads to increased QoL and reduced anxiety and depression. Secondary goals are the identification of psychosocial and medical predictors, mediators, and moderators of treatment efficacy. Moreover, differences between patients with ICDs implanted for primary vs. secondary prevention will be explored. Conclusion: This project will evaluate the feasibility and efficacy of an internet based intervention for ICD-patients. Furthermore, the investigators aim at identifying predictors and mediators of treatment outcome. This will improve interdisciplinary care for ICD-patients; further applications for other cardiovascular disorders as well as preventive programs for heart failure seem possible.

Detailed Description
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See Summary.

Official Title
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Remote Care for Reducing Cardiac Fear, Fear of Dying, Depression, and Increasing Quality of Life in ICD-Patients With Cardiac Insufficiency/at Risk for Fatal Cardiac Arrhythmia.

Conditions
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Anxiety, Depression, Quality of Life

Intervention / Treatment
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* Behavioral: ICD-Forum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Implanted ICD Internet access can be installed during completion of the prevention program Exclusion Criteria: Medical reasons preventing participation of the prevention program (e.g. emergency hospitalization) for more than one week of the program Suicidality (Patients with scores > 8 on the depression subscale of the HADS will be assessed via interviews conducted by a qualified psychologist) Severe cognitive impairment (< 17 points in the MMST; Kessler, J., Markowitsch, H. J. & Denzler, P. (2000). Mini-Mental-Status-Test (MMST). Göttingen: Beltz Test GMBH. [Deutsche Adaption]) Insufficient command of German to follow the intervention program Current ICD-10 diagnosis: F1x: Mental and behavioral disorders due to psychoactive substance use F2x: Schizophrenia, schizotypal and delusional disorders F30: Manic Episode F31: Bipolar affective disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment as usual plus remote care<br>The same treatment as described under treatment as usual plus participation in the intervention ICD-Forum. | Behavioral: ICD-Forum<br>* The CBT based internet program ICD-Forum is designed to increase QoL, and decrease anxiety and depression in ICD-patients. The program includes a therapist moderated asynchronous discussion group and content focused modules following a six weeks schedule: Introduction to participants and online system Knowledge regarding ICDs Strategies for behavior change Psychological models for anxiety and depression Strategies to cope with avoidance, anxiety and depression Resume, evaluation, resolution of open questions, goal setting, good bye<br>* Other names: REACH-ICD;|
| No Intervention: Treatment as usual<br>Standard information provided by hospitals on ICD-technology as well as consequences of ICD-implantation plus medical aftercare including cardiology appointments at 1, 3, and 6 months, and one year after ICD-implantation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of psychosocial well-being (combined score for measures of anxiety, depression, and quality of life) from week 1 (T1) to one week after (T2) the 6-weeks prevention program | assessment tools for aspects of psychosocial well-being (German versions will be used): Anxiety: Cardiac Fear Questionnaire (Hoyer & Eifert, 2001); Depression: Hospital Anxiety and Depression Scale (Hinz & Brähler, 2011); QoL: MOS 36-item short-form health survey (Ware & Sherbourne, 1992) | up to 1 week before ICD-implantation (T0), in week 1 (T1) and within one week after (T2) the 6-weeks prevention program, and 12 months after T0 (T3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Health status 2. ICD-related trauma 3. Life-style factors 4. ICD-Related concerns 5. Psychological well-being 6. Type-D personality 7. Social support 8. Economic efficiency | assessed by NYHA-class, LVEF, blood pressure measured through IES, Maercker, & Schützwohl, 1998 and PDEQ, Fuglsang, Moergeli, et al., 2002 and FSAS, Kuhl, et al., 2006 measured through smoking, BMI measured through FPAS, Burns, et.al., 2005 and ICD-Safety and Concerns Scales, Crössmann, 2005 measured through SCL-9-K, Klaghofer & Brähler, 2001 measured through DS14, Grande, et al., 2004 measured through BSSS, Schulze, & Schwarzer, 2003 measured according to Schweikert, Hahmann & Leidl, 2008 | up to 1 week before ICD-implantation (T0), in week 1 (T1) and within one week after (T2) the 6-weeks prevention program, and 12 months after T0 (T3) | 
| psychophysiological parameters: heart rate variability | time- and frequency domain parameters of HRV (Camm et al., 1996) | up to 1 week before ICD-implantation (T0) and 1, 3, 6, and 12 months after ICD-implantation | 
| biometric markers: 1. proinflammatory cytokines 2. coagulation parameters | ELISA analysis of IL-1β, IL-6, TNF-α Fibrinogen | up to 1 week before ICD-implantation (T0) and 6 months after ICD-implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implantable Cardioverter Defibrillators, Heart Failure, Anxiety, Depression, Quality of Life, Remote Care, Prevention