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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Wuerzburg
Center of Cardiovascular Medicine, Bad Neustadt
Hospital Rothenburg ob der Tauber
Information provided by (Responsible Party):
Paul Pauli, Wuerzburg University Hospital
ClinicalTrials.gov Identifier:
NCT01589913
First received: October 5, 2011
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Anxiety
Depression
Quality of Life
Behavioral: ICD-Forum

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Wuerzburg University Hospital:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]
    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 [ 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 ]
    1. ELISA analysis of IL-1β, IL-6, TNF-α
    2. Fibrinogen


Estimated Enrollment: 200
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)
Arms Assigned Interventions
Experimental: Treatment as usual plus remote care 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
Other Names:
  • www.icd-forum.de
  • icd-forum.de
  • REACH-ICD
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589913

Locations
Germany
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
Sponsors and Collaborators
Paul Pauli
University of Wuerzburg
Center of Cardiovascular Medicine, Bad Neustadt
Hospital Rothenburg ob der Tauber
Investigators
Principal Investigator: Paul Pauli, Prof. Dr. University of Würzburg
  More Information

Additional Information:
Publications:
Responsible Party: Paul Pauli, Chair of the Department of Psychology I, Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT01589913     History of Changes
Other Study ID Numbers: UKW-CHFC-G2
Study First Received: October 5, 2011
Last Updated: June 14, 2013
Health Authority: Germany: Ethics Commission
Germany: Federal Ministry of Education and Research

Keywords provided by Wuerzburg University Hospital:
Implantable Cardioverter Defibrillators
Heart Failure
Anxiety
Depression
Quality of Life
Remote Care
Prevention

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 20, 2014