AnxietyREACH-ICDNCT01589913
REmote Web Assisted Care for Heart Failure Patients With Implantable Cardioverter Defibrillators
A study testing ICD-Forum in people with Anxiety and Depression, run by Wuerzburg University Hospital at 7 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anxiety, Depression, Quality of Life
- What is being tested?
- ICD-Forum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 7 sitesGermany
- Study dates
- May 2012to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Implanted ICD
- Internet access can be installed during completion of the prevention program
Who cannot join
- 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
Show all 9Show fewer
- F2x: Schizophrenia, schizotypal and delusional disorders
- F30: Manic Episode
- F31: Bipolar affective disorder
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Klinikum Aschaffenburg-Alzenau
Aschaffenburg, Hesse, 63739
Department of Cardiology, Center of Cardiovascular Medicine
Bad Neustadt an der Saale, Bavaria, 97616
Klinik Bad Wörishofen
Bad Wörishofen, Bavaria, 86825
Klinik für Kardiologie und Pulmologie, Medizinische Hochschule Brandenburg
Brandenburg, 14770
Department of Internal Medicine, Krankenhaus Rothenburg ob der Tauber
Rothenburg upon Tauber, Bavaria, 91541
University of Wuerzburg
Würzburg, Bavaria, 97070
Wuerzburg University Hospital, Department of Medicine I (Cardiology)
Würzburg, Bavaria, 97080
About this study
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.
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.
Read more
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.
Read the detailed description
See Summary.
- Conditions
- Anxiety, Depression, Quality of Life
- Being tested
- ICD-Forum
- Keywords
- Implantable Cardioverter Defibrillators, Heart Failure, Anxiety, Depression, Quality of Life, Remote Care, Prevention
- Medical subject headings
- Anxiety Disorders, Depression, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD-ForumBehavioural
Also called www.icd-forum.de, icd-forum.de, REACH-ICD
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual plus remote care | Experimental | The same treatment as described under "treatment as usual" plus participation in the intervention "ICD-Forum". Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
- 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
Measured: 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
time- and frequency domain parameters of HRV (Camm et al., 1996)
Measured: 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
- ELISA analysis of IL-1β, IL-6, TNF-α
- Fibrinogen
Measured: up to 1 week before ICD-implantation (T0) and 6 months after ICD-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wuerzburg, Campus Bad Neustadt, Hospital Rothenburg ob der Tauber, University Hospital Brandenburg, Klinikum Aschaffenburg-Alzenau, Klinikum Bad Woerishofen, University of Leipzig
- Responsible party
- Sponsor
- Investigators
- Paul Pauli, Prof. Dr., Principal investigator, University of WürzburgStefan M Schulz, Dr., Principal investigator, University of Würzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589913
- Sponsor's protocol ID
- UKW-CHFC-G2
- Acronym
- REACH-ICD
- Status last verified
- Apr 2019
- First submitted
- 5 Oct 2011
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 21826541Schulz 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.
PubMed 23110854Schulz 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.
PubMed 30957867
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01589913
- Acronym / sponsor ID
- REACH-ICD / UKW-CHFC-G2
- Conditions
- Anxiety, Depression, Quality of Life
- Keywords
- Implantable Cardioverter Defibrillators, Heart Failure, Anxiety, Depression, Quality of Life, Remote Care, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- University of Wuerzburg, Campus Bad Neustadt, Hospital Rothenburg ob der Tauber, University Hospital Brandenburg, Klinikum Aschaffenburg-Alzenau, Klinikum Bad Woerishofen, University of Leipzig
- Study start
- May 2012 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 2 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual plus remote care | Experimental | Behavioral: ICD-ForumThe same treatment as described under "treatment as usual" plus participation in the intervention "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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Implanted ICD
- Internet access can be installed during completion of the prevention program
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICD-ForumAlso: www.icd-forum.de, icd-forum.de, REACH-ICDThe 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 | Behavioural | Treatment as usual plus remote care |
Primary outcome
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)
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)
3 secondary outcomes
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)
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
biometric markers: 1. proinflammatory cytokines 2. coagulation parameters
Time frame: up to 1 week before ICD-implantation (T0) and 6 months after ICD-implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Background: PubMed 21826541Schulz SM, Pauli P. [Internet therapy for ICD-patients]. Herzschrittmacherther Elektrophysiol. 2011 Sep;22(3):166-73. doi: 10.1007/s00399-011-0145-y. German.
- Background: PubMed 23110854Schulz 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.
- Results publication: PubMed 30957867Schulz 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.
- Homepage for ICD-Forum, the remote care program evaluated in REACH-ICDLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Pauli, Prof. Dr. principal investigator
University of Würzburg
Stefan M Schulz, Dr. principal investigator
University of Würzburg
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICD-Forum in people with Anxiety and Depression, run by Wuerzburg University Hospital at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01589913, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.