REmote Web Assisted Care for Heart Failure Patients With Implantable Cardioverter Defibrillators
Condition: Anxiety; Depression; Quality of Life
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

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.
    

Intervention name(s): ICD-Forum
Intervention type(s): Behavioral
Intervention description(s): 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
Other intervention name(s): www.icd-forum.de; icd-forum.de; REACH-ICD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Implantable Cardioverter Defibrillators; Heart Failure; Anxiety; Depression; Quality of Life; Remote Care; Prevention