REmote Web Assisted Care for Heart Failure Patients With Implantable Cardioverter Defibrillators
NCT ID: NCT01589913
Last Updated: 2019-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
118 participants
INTERVENTIONAL
2012-05-31
2016-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Treatment as usual plus remote care
The same treatment as described under "treatment as usual" plus participation in the intervention "ICD-Forum".
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
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.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Internet access can be installed during completion of the prevention program
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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University of Wuerzburg
OTHER
Campus Bad Neustadt
OTHER
Hospital Rothenburg ob der Tauber
UNKNOWN
University Hospital Brandenburg
UNKNOWN
Klinikum Aschaffenburg-Alzenau
OTHER
Klinikum Bad Woerishofen
UNKNOWN
University of Leipzig
OTHER
Wuerzburg University Hospital
OTHER
Responsible Party
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Principal Investigators
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Paul Pauli, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Würzburg
Stefan M Schulz, Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Würzburg
Locations
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Department of Cardiology, Center of Cardiovascular Medicine
Bad Neustadt an der Saale, Bavaria, Germany
Klinik Bad Wörishofen
Bad Wörishofen, Bavaria, Germany
Department of Internal Medicine, Krankenhaus Rothenburg ob der Tauber
Rothenburg upon Tauber, Bavaria, Germany
University of Wuerzburg
Würzburg, Bavaria, Germany
Wuerzburg University Hospital, Department of Medicine I (Cardiology)
Würzburg, Bavaria, Germany
Klinikum Aschaffenburg-Alzenau
Aschaffenburg, Hesse, Germany
Klinik für Kardiologie und Pulmologie, Medizinische Hochschule Brandenburg
Brandenburg, , Germany
Countries
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References
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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.
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.
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.
Related Links
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Homepage for ICD-Forum, the remote care program evaluated in REACH-ICD
Other Identifiers
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UKW-CHFC-G2
Identifier Type: -
Identifier Source: org_study_id
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