REmote Web Assisted Care for Heart Failure Patients With Implantable Cardioverter Defibrillators (REACH-ICD)

Wuerzburg University Hospital

Status: Completed

Conditions: Quality of Life; Depression; Anxiety

Treatments: Behavioral: ICD-Forum

Study type: Interventional

Funder types: Other

Identifiers

NCT01589913

UKW-CHFC-G2

Details and patient eligibility

About

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.

Full description

See Summary.

Enrollment: 118 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Treatment as usual plus remote care

Experimental group

Description:

The same treatment as described under "treatment as usual" plus participation in the intervention "ICD-Forum".

Treatment:

Behavioral: ICD-Forum

Treatment as usual

No Intervention group

Description:

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.