REmote Web Assisted Care for Heart Failure Patients With Implantable Cardioverter Defibrillators (REACH-ICD)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||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.|
- 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 [ Time Frame: 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) ] [ Designated as safety issue: No ]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)
- 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 [ Time Frame: 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) ] [ Designated as safety issue: No ]
- 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
- psychophysiological parameters: heart rate variability [ Time Frame: up to 1 week before ICD-implantation (T0) and 1, 3, 6, and 12 months after ICD-implantation ] [ Designated as safety issue: No ]time- and frequency domain parameters of HRV (Camm et al., 1996)
- biometric markers: 1. proinflammatory cytokines 2. coagulation parameters [ Time Frame: up to 1 week before ICD-implantation (T0) and 6 months after ICD-implantation ] [ Designated as safety issue: No ]
- ELISA analysis of IL-1β, IL-6, TNF-α
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
|Experimental: Treatment as usual plus remote care||
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:
No Intervention: treatment as usual
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589913
|Klinik Bad Wörishofen|
|Bad Wörishofen, Bavaria, Germany, 86825|
|Department of Cardiology, Center of Cardiovascular Medicine|
|Bad Neustadt, BY, Germany, 97616|
|Department of Internal Medicine, Krankenhaus Rothenburg ob der Tauber|
|Rothenburg ob der Tauber, BY, Germany, 91541|
|University of Wuerzburg|
|Wuerzburg, BY, Germany, 97070|
|Wuerzburg University Hospital, Department of Medicine I (Cardiology)|
|Wuerzburg, BY, Germany, 97080|
|Principal Investigator:||Paul Pauli, Prof. Dr.||University of Würzburg|