NCT01589913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

3.2 years

First QC Date

October 5, 2011

Last Update Submit

April 29, 2019

Conditions

AnxietyDepressionQuality of Life

Keywords

Implantable Cardioverter DefibrillatorsHeart FailureAnxietyDepressionQuality of LifeRemote CarePrevention

Outcome Measures

Primary Outcomes (1)

  • 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

    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)

    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)

Secondary Outcomes (3)

  • 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)

  • psychophysiological parameters: heart rate variability

    up to 1 week before ICD-implantation (T0) and 1, 3, 6, and 12 months after ICD-implantation

  • biometric markers: 1. proinflammatory cytokines 2. coagulation parameters

    up to 1 week before ICD-implantation (T0) and 6 months after ICD-implantation

Study Arms (2)

Treatment as usual plus remote care

EXPERIMENTAL

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

Behavioral: ICD-Forum

Treatment as usual

NO INTERVENTION

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.

Interventions

ICD-ForumBEHAVIORAL

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

Also known as: www.icd-forum.de, icd-forum.de, REACH-ICD
Treatment as usual plus remote care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Implanted ICD
  • Internet access can be installed during completion of the prevention program

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Department of Cardiology, Center of Cardiovascular Medicine

Bad Neustadt an der Saale, Bavaria, 97616, Germany

Location

Klinik Bad Wörishofen

Bad Wörishofen, Bavaria, 86825, Germany

Location

Department of Internal Medicine, Krankenhaus Rothenburg ob der Tauber

Rothenburg upon Tauber, Bavaria, 91541, Germany

Location

University of Wuerzburg

Würzburg, Bavaria, 97070, Germany

Location

Wuerzburg University Hospital, Department of Medicine I (Cardiology)

Würzburg, Bavaria, 97080, Germany

Location

Klinikum Aschaffenburg-Alzenau

Aschaffenburg, Hesse, 63739, Germany

Location

Klinik für Kardiologie und Pulmologie, Medizinische Hochschule Brandenburg

Brandenburg, 14770, Germany

Location

Related Publications (3)

  • Schulz SM, Pauli P. [Internet therapy for ICD-patients]. Herzschrittmacherther Elektrophysiol. 2011 Sep;22(3):166-73. doi: 10.1007/s00399-011-0145-y. German.

    PMID: 21826541BACKGROUND

  • Schulz SM, Massa C, Grzbiela A, Dengler W, Wiedemann G, Pauli P. Implantable cardioverter defibrillator shocks are prospective predictors of anxiety. Heart Lung. 2013 Mar-Apr;42(2):105-11. doi: 10.1016/j.hrtlng.2012.08.006. Epub 2012 Oct 27.

    PMID: 23110854BACKGROUND

  • Schulz SM, Ritter O, Zniva R, Nordbeck P, Wacker C, Jack M, Groschup G, Deneke T, Puppe F, Ertl G, Angermann C, Stork S, Pauli P. Efficacy of a web-based intervention for improving psychosocial well-being in patients with implantable cardioverter-defibrillators: the randomized controlled ICD-FORUM trial. Eur Heart J. 2020 Mar 14;41(11):1203-1211. doi: 10.1093/eurheartj/ehz134.

    PMID: 30957867RESULT

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepressionHeart Failure

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorHeart DiseasesCardiovascular Diseases

Study Officials

  • Paul Pauli, Prof. Dr.

    University of Würzburg

    PRINCIPAL INVESTIGATOR

  • Stefan M Schulz, Dr.

    University of Würzburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2011

First Posted

May 2, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2015

Study Completion

August 1, 2016

Last Updated

May 1, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(7)