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

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.

Conditions

• Anxiety
• Depression
• Quality of Life

Interventions

BEHAVIORAL

ICD-Forum

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: 1. Introduction to participants and online system 2. Knowledge regarding ICDs 3. Strategies for behavior change 4. Psychological models for anxiety and depression 5. Strategies to cope with avoidance, anxiety and depression 6. Resume, evaluation, resolution of open questions, goal setting, good bye

Sponsors & Collaborators

• University of Wuerzburg

  collaborator OTHER

• Campus Bad Neustadt

  collaborator OTHER

• Hospital Rothenburg ob der Tauber

  collaborator UNKNOWN

• University Hospital Brandenburg

  collaborator UNKNOWN

• Klinikum Aschaffenburg-Alzenau

  collaborator OTHER

• Klinikum Bad Woerishofen

  collaborator UNKNOWN

• University of Leipzig

  collaborator OTHER

• Wuerzburg University Hospital

  lead OTHER

Principal Investigators

• Paul Pauli, Prof. Dr. · University of Würzburg

• Stefan M Schulz, Dr. · University of Würzburg

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2015-07-31

Completion

2016-08-31

Countries

• Germany

Study Locations