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

Not Applicable

Completed

• Conditions: Anxiety; Quality of Life; Depression
• Interventions: Behavioral: ICD-Forum

• Registration Number: NCT01589913
• Lead Sponsor: Wuerzburg University Hospital

Brief Summary

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

See Summary.

Study Timeline

• Study First Submitted: 2011-10-05
• Study Start: 2012-05
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-02
• Primary Completion: 2015-07
• Study Completion: 2016-08
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as usual plus remote care	ICD-Forum	The same treatment as described under "treatment as usual" plus participation in the intervention "ICD-Forum".

Primary Outcome Measures

Name	Time	Method
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	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)	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)

Secondary Outcome Measures

Name	Time	Method
biometric markers: 1. proinflammatory cytokines 2. coagulation parameters	up to 1 week before ICD-implantation (T0) and 6 months after ICD-implantation	1. ELISA analysis of IL-1β, IL-6, TNF-α; 2. Fibrinogen
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	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)	1. assessed by NYHA-class, LVEF, blood pressure; 2. measured through IES, Maercker, \& Schützwohl, 1998 and PDEQ, Fuglsang, Moergeli, et al., 2002 and FSAS, Kuhl, et al., 2006; 3. measured through smoking, BMI; 4. measured through FPAS, Burns, et.al., 2005 and ICD-Safety and Concerns Scales, Crössmann, 2005; 5. measured through SCL-9-K, Klaghofer \& Brähler, 2001; 6. measured through DS14, Grande, et al., 2004; 7. measured through BSSS, Schulze, \& Schwarzer, 2003; 8. measured according to Schweikert, Hahmann \& Leidl, 2008
psychophysiological parameters: heart rate variability	up to 1 week before ICD-implantation (T0) and 1, 3, 6, and 12 months after ICD-implantation	time- and frequency domain parameters of HRV (Camm et al., 1996)

Trial Locations

Locations (7)

Klinik für Kardiologie und Pulmologie, Medizinische Hochschule Brandenburg; 🇩🇪 Brandenburg, Germany

Klinikum Aschaffenburg-Alzenau; 🇩🇪 Aschaffenburg, Hessen, Germany

University of Wuerzburg; 🇩🇪 Wuerzburg, BY, Germany

Wuerzburg University Hospital, Department of Medicine I (Cardiology); 🇩🇪 Wuerzburg, BY, Germany

Department of Cardiology, Center of Cardiovascular Medicine; 🇩🇪 Bad Neustadt An Der Saale, BY, Germany

Klinik Bad Wörishofen; 🇩🇪 Bad Wörishofen, Bavaria, Germany

Department of Internal Medicine, Krankenhaus Rothenburg ob der Tauber; 🇩🇪 Rothenburg ob der Tauber, BY, Germany