Clinical trial NCT01589913: REmote Web Assisted Care for Heart Failure Patients With Implantable Cardioverter Defibrillators
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Quality of Life
Keywords: Implantable Cardioverter Defibrillators
Heart Failure
Anxiety
Depression
Quality of Life
Remote Care
Prevention
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: University of Wuerzburg
name: Campus Bad Neustadt
name: Hospital Rothenburg ob der Tauber
name: University Hospital Brandenburg
name: Klinikum Aschaffenburg-Alzenau
name: Klinikum Bad Woerishofen
name: University of Leipzig
First posted: 2012-05-02
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: See Summary.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 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:
measure: 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
timeFrame: 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)
measure: psychophysiological parameters: heart rate variability
timeFrame: up to 1 week before ICD-implantation (T0) and 1, 3, 6, and 12 months after ICD-implantation
measure: biometric markers: 1. proinflammatory cytokines 2. coagulation parameters
timeFrame: up to 1 week before ICD-implantation (T0) and 6 months after ICD-implantation
Other outcomes:
Locations:
city: Bad Wörishofen
country: Germany
facility: Klinik Bad Wörishofen
state: Bavaria
city: Bad Neustadt An Der Saale
country: Germany
facility: Department of Cardiology, Center of Cardiovascular Medicine
state: BY
city: Rothenburg ob der Tauber
country: Germany
facility: Department of Internal Medicine, Krankenhaus Rothenburg ob der Tauber
state: BY
city: Wuerzburg
country: Germany
facility: University of Wuerzburg
state: BY
city: Wuerzburg
country: Germany
facility: Wuerzburg University Hospital, Department of Medicine I (Cardiology)
state: BY
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg-Alzenau
state: Hessen
city: Brandenburg
country: Germany
facility: Klinik für Kardiologie und Pulmologie, Medizinische Hochschule Brandenburg
Study officials:
affiliation: University of Würzburg
name: Paul Pauli, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Würzburg
name: Stefan M Schulz, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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. German.
citation: 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.
citation: 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.