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

Depression Clinical Trial

— REACH-ICD  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589913
• Other study ID #: UKW-CHFC-G2
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: August 2016

Study information

• Verified date: April 2019
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See Summary.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: August 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Disorder
• Quality of Life

Intervention

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: 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

Locations

Country	Name	City	State
Germany	Klinikum Aschaffenburg-Alzenau	Aschaffenburg	Hessen
Germany	Department of Cardiology, Center of Cardiovascular Medicine	Bad Neustadt An Der Saale	BY
Germany	Klinik Bad Wörishofen	Bad Wörishofen	Bavaria
Germany	Klinik für Kardiologie und Pulmologie, Medizinische Hochschule Brandenburg	Brandenburg
Germany	Department of Internal Medicine, Krankenhaus Rothenburg ob der Tauber	Rothenburg ob der Tauber	BY
Germany	University of Wuerzburg	Wuerzburg	BY
Germany	Wuerzburg University Hospital, Department of Medicine I (Cardiology)	Wuerzburg	BY

Sponsors (8)

Lead Sponsor	Collaborator
Wuerzburg University Hospital	Campus Bad Neustadt, Hospital Rothenburg ob der Tauber, Klinikum Aschaffenburg-Alzenau, Klinikum Bad Woerishofen, University Hospital Brandenburg, University of Leipzig, University of Wuerzburg

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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

Schulz SM, Ritter O, Zniva R, Nordbeck P, Wacker C, Jack M, Groschup G, Deneke T, Puppe F, Ertl G, Angermann C, Störk S, Pauli P. Efficacy of a web-based intervention for improving psychosocial well-being in patients with implantable cardioverter-defibril — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	assessed by NYHA-class, LVEF, blood pressure; measured through IES, Maercker, & Schützwohl, 1998 and PDEQ, Fuglsang, Moergeli, et al., 2002 and FSAS, Kuhl, et al., 2006; measured through smoking, BMI; measured through FPAS, Burns, et.al., 2005 and ICD-Safety and Concerns Scales, Crössmann, 2005; measured through SCL-9-K, Klaghofer & Brähler, 2001; measured through DS14, Grande, et al., 2004; measured through BSSS, Schulze, & Schwarzer, 2003; measured according to Schweikert, Hahmann & Leidl, 2008	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	psychophysiological parameters: heart rate variability	time- and frequency domain parameters of HRV (Camm et al., 1996)	up to 1 week before ICD-implantation (T0) and 1, 3, 6, and 12 months after ICD-implantation
Secondary	biometric markers: 1. proinflammatory cytokines 2. coagulation parameters	ELISA analysis of IL-1ß, IL-6, TNF-a; Fibrinogen	up to 1 week before ICD-implantation (T0) and 6 months after ICD-implantation

External Links

•   Homepage for ICD-Forum, the remote care program evaluated in REACH-ICD