Ventricular Assist DeviceSELMANCT04234230
Improved Self-management for Patients on Ventricular Assist Device (VAD)
An observational study of Ventricular Assist Device and Self-management, run by University of Freiburg at 4 sites in Germany.
Trial summary
The number of patients with end-stage heart disease requiring the implantation of ventricular assist devices (VAD) is steadily increasing. Living with a VAD exposes the patients to multiple challenges and the need to learn complex self-management skills. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Assist Device, Self-management, Psychological Factors
- What is being tested?
- Prevalence Survey
- How many people
- 393 participants
- Where
- 4 sitesGermany
- Study dates
- 1 Oct 2019to 30 Sep 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients implanted with a ventricular assist device in the outpatient setting of four heart centers in Germany (Freiburg, Berlin, Bad Oeynhausen and Leipzig).
Who may be able to join
- Outpatient at the respective heart center
- Living in a home environment
- On device between 3 months and 3 years
- 18 years and older
- No contraindications (e.g. cognitive, language)
- Signed Informed Consent
Who cannot join
- In-patient stay
- Not living in a home environment (e.g. assisted living)
- On device less than 3 months or more than 3 years
- Underage
- Contraindications (e.g. cognitive, language)
- No signed Informed Consent
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Heart and Diabetes Center North Rhine-Westphalia
Bad Oeynhausen, North Rhine-Westphalia, 32545
German Heart Center
Berlin, 13353
University Heart Center Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79110
Leipzig Heart Center
Leipzig, Saxony, 04289
About this study
Official title: Improved Health Care for People With Chronic Heart Disease and Implanted Cardiac Support Through Curricular Self-management - Phase 1: Prevalence Study
The number of patients with end-stage heart disease requiring the implantation of ventricular assist devices (VAD) is steadily increasing. Living with a VAD exposes the patients to multiple challenges and the need to learn complex self-management skills. Inadequate self-management can lead to serious complications (e.g. bleeding or wound infections) and impair the psychosocial outcome. This study aims to provide multi-centered actual analysis of self-management capabilities as well as analyzing moderating predictors in VAD patients through standardized prevalence assessment. Using a cross-sectional design, this prevalence study will be conducted at four established German heartcenters (Freiburg, Berlin, Bad Oeynhausen, Leipzig). VAD-patients are questioned about their self-management skills using standardized Patient-reported outcome (PRO) measures. Secondary PRO measures include health-related quality of life, symptoms of anxiety and depression, post-traumatic stress symptoms, social support, and changed body-image. Relevant complications (bleeding, wound infections, thromboembolic neurological events) are taken from the patient records. Based on a conservative sample size estimation inclusion of 450 patients is envisioned. The expected results may contribute to an improved assessment of the current situation in terms of self-management skills and needs for curricular training concepts and psychosocial concomitant therapy. Long-term, the study results contribute to improve the health care for long-term VAD patients.
Read the detailed description
The number of patients with end-stage heart disease requiring the implantation of ventricular assist devices (VAD) is steadily increasing. Due to advanced compensatory technological developments, VAD support has been established as a recognized therapy concept for the long-term care of those affected. Indications include a multi-year bridging therapy (up to 10 years) and increasingly a destination therapy. The Euromacs Register published the second report in 2018 and reported 2,947 registered VAD implantations in 2016 (+257 percent). Euromacs further points to a rising trend and demand for the use of VAD systems. In Germany, an increase of VAD implantation by 36.6 percent has been reported since 2011. The position paper of the German Society of Cardiology (2016) points to the fact that the range of indications for VAD implantation for patients with chronic heart disease will continue to change. The ISHLT Guideline (International Society for Heart and Lung Transplantation), published in 2018, calls for psychosocial care and standardized self-management skills for patients before, during, and in the long-term after VAD implantation. This is currently being implemented inconsistently in terms of structure and quality in German cardiac centers. After VAD implantation, patients and their relatives must be able to follow a complex therapeutic regimen. They need comprehensive knowledge as well as self-management skills for the safe management of everyday life in a domestic setting. These self-management capabilities include the so-called device handling (for example dealing with the technical equipment including battery replacement and controller monitoring), to perform the wound care of the driveline, to carry out anticoagulation measurements and adapted revenues of oral anticoagulant, to take further medication, to monitor vital signs (for example blood pressure, temperature) and, in the case of symptoms, to take adequate measures to prevent further complications (for example prompt information from the heart center on the onset of symptoms). In addition, lifestyle changes are an essential part of the success of long-term therapy. This requires a sufficient degree of self-management ability and mental stability. In addition, it is important to emotionally accept the dependence of a device on the heart, the changed body image, to cope with fears of (real potential) malfunctions and complications and to build up a subjective quality of life with a constant, visible and tangible companion at heart. The mental health of all those affected is considered to be in need of observation, although there is currently no reliable prevalence data on mental disorders. In a first survey in 2006, 64% had at least one psychologically / psychiatric treatment requiring diagnosis. All this shows, the challenges VAD patients have to face are complex. Thus, this study aims to provide multi-centered actual analysis of self-management capabilities as well as analyzing moderating predictors in VAD patients through standardized PRO prevalence assessment. The prevalence survey should be conducted in all outpatients (at least 3 months up to a maximum of 3 years at the VAD) in four established German cardiac centers (Freiburg, Berlin, Bad Oeynhausen, Leipzig). The study focuses on those involved in outpatient care, as they had to integrate the VAD into their daily lives after implantation and are able to report deficits, resources and needs on the basis of their experience of self-management. As an assessment instrument a standardized PRO measure was chosen to identify self-management skills and needs. Secondary PRO measures include health-related quality of life, symptoms of anxiety, depression and post-traumatic stress, as well as social support. Relevant complications (bleeding, wound infections, thromboembolic neurological events) are taken from the patient records. Based on a conservative sample size estimation inclusion of 450 patients is envisioned. The expected results may contribute to an improved assessment of the current situation in terms of self-management skills and needs for curricular training concepts and psychosocial concomitant therapy. Long-term, the study results contribute to improve the health care for long-term VAD patients. The study is planned to continue in a second and third phase to develop and test a standardized self-management care for VAD patients in Germany.
- Being tested
- Prevalence Survey
- Keywords
- Ventricular Assist Device, Self-management, Psychosocial Factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevalence SurveyOther
Questionnaire survey on self-management
| Study group | Role | What they receive |
|---|---|---|
| VAD Patients | Patients with implanted ventricular assist device in the outpatient setting Receives: Other: Prevalence Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-management Skills
As an assessment instrument a standardized PRO measure was chosen to identify self-management skills and needs.
Measured: October 2019 till January 2020
Secondary outcomes (5)
Health-related Quality of Life
The experienced health-related quality of life of the participants measured with a selfassessment questionnaire (QoL-VAD, KCCQ).
Measured: October 2019 till January 2020
Social Support
The experienced social support of the participants measured with a selfassessment questionnaire (F-SozU).
Measured: October 2019 till January 2020
Symptoms of Anxiety
Symptoms of anxiety measured via screening tool (HADS).
Measured: October 2019 till January 2020
Symptoms of Depression
Symptoms of depression measured via screening tool (HADS, PHQ-9).
Measured: October 2019 till January 2020
Symptoms of Posttraumatic Stress Disorder
Symptoms of posttraumatic stress disorder measured via screening tool (PTSD-7).
Measured: October 2019 till January 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Oct 2019
- Primary completion31 Aug 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ventricular Assist DeviceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- University Heart Center Freiburg - Bad Krozingen, Heart and Diabetes Center North-Rhine Westfalia, German Heart Center, Heart Center Leipzig - University Hospital
- Responsible party
- Principal investigator, Christiane Kugler, University of Freiburg
- Investigators
- Christiane Kugler, Prof. Dr., Study director, University of FreiburgChristiane Kugler, Prof. Dr., Principal investigator, University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234230
- Sponsor's protocol ID
- 01VSF18012
- Acronym
- SELMA
- Status last verified
- Nov 2020
- First submitted
- 2 Oct 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kugler C, Spielmann H, Albert W, Lauenroth V, Spitz-Koeberich C, Semmig-Koenze S, Staus P, Tigges-Limmer K; SELMA Study Group. Professional Employment in Patients on Ventricular Assist Device Support-A National Multicenter Survey Study. ASAIO J. 2024 May 1;70(5):348-355. doi: 10.1097/MAT.0000000000002124. Epub 2024 Jan 3.
PubMed 38170263Spielmann H, Tigges-Limmer K, Albert W, Spitz-Koberich C, Semmig-Konze S, Staus P, Herrmann-Lingen C, Sandau KE, Okeson B, Geyer S, Kugler C; Selma Study Group. Health-Related Quality of Life in Patients With Ventricular Assist Device: Psychometric Evaluation of the German Version of the Quality of Life With a Ventricular Assist Device Questionnaire. J Cardiovasc Nurs. 2024 Nov-Dec 01;39(6):571-582. doi: 10.1097/JCN.0000000000001064. Epub 2023 Nov 22.
PubMed 37991265Spielmann H, Albert W, Semmig-Konze S, Lauenroth V, Spitz-Koberich C, Staus P, Tigges-Limmer K, Kugler C; SELMA Study Group. High level of psychosocial adjustment in patients on ongoing ventricular assist device support in the years one to three after VAD implantation-A national multi-center Study. Heart Lung. 2024 Jan-Feb;63:92-97. doi: 10.1016/j.hrtlng.2023.10.003. Epub 2023 Oct 12.
PubMed 37837720Kugler C, Spielmann H, Seemann M, Lauenroth V, Wacker R, Albert W, Spitz-Koeberich C, Semmig-Koenze S, von Cube M, Tigges-Limmer K. Self-management for patients on ventricular assist device support: a national, multicentre study: protocol for a 3-phase study. BMJ Open. 2021 May 5;11(5):e044374. doi: 10.1136/bmjopen-2020-044374.
PubMed 33952544Spielmann H, Seemann M, Friedrich N, Tigges-Limmer K, Albert W, Semmig-Konze S, Spitz-Koberich C, Kugler C. Self-management with the therapeutic regimen in patients with ventricular assist device (VAD) support - a scoping review. Heart Lung. 2021 May-Jun;50(3):388-396. doi: 10.1016/j.hrtlng.2021.01.019. Epub 2021 Feb 20.
PubMed 33621837
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Health Care for People With Chronic Heart Disease and Implanted Cardiac Support Through Curricular Self-management - Phase 1: Prevalence Study
- ClinicalTrials.gov ID
- NCT04234230
- Acronym / sponsor ID
- SELMA / 01VSF18012
- Keywords
- Ventricular Assist Device, Self-management, Psychosocial Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- University of FreiburgUniversity, hospital or other
- Collaborators
- University Heart Center Freiburg - Bad Krozingen, Heart and Diabetes Center North-Rhine Westfalia, German Heart Center, Heart Center Leipzig - University Hospital
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 21 Jan 2020 (actual)
- 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.
The number of patients with end-stage heart disease requiring the implantation of ventricular assist devices (VAD) is steadily increasing. Living with a VAD exposes the patients to multiple challenges and the need to learn complex self-management skills. Inadequate self-management can lead to serious complications (e.g. bleeding or wound infections) and impair the psychosocial outcome. This study aims to provide multi-centered actual analysis of self-management capabilities as well as analyzing moderating predictors in VAD patients through standardized prevalence assessment. Using a cross-sectional design, this prevalence study will be conducted at four established German heartcenters (Freiburg, Berlin, Bad Oeynhausen, Leipzig). VAD-patients are questioned about their self-management skills using standardized Patient-reported outcome (PRO) measures. Secondary PRO measures include health-related quality of life, symptoms of anxiety and depression, post-traumatic stress symptoms, social support, and changed body-image. Relevant complications (bleeding, wound infections, thromboembolic neurological events) are taken from the patient records. Based on a conservative sample size estimation inclusion of 450 patients is envisioned. The expected results may contribute to an improved assessment of the current situation in terms of self-management skills and needs for curricular training concepts and psychosocial concomitant therapy. Long-term, the study results contribute to improve the health care for long-term VAD patients.
Detailed description
The number of patients with end-stage heart disease requiring the implantation of ventricular assist devices (VAD) is steadily increasing. Due to advanced compensatory technological developments, VAD support has been established as a recognized therapy concept for the long-term care of those affected. Indications include a multi-year bridging therapy (up to 10 years) and increasingly a destination therapy. The Euromacs Register published the second report in 2018 and reported 2,947 registered VAD implantations in 2016 (+257 percent). Euromacs further points to a rising trend and demand for the use of VAD systems. In Germany, an increase of VAD implantation by 36.6 percent has been reported since 2011. The position paper of the German Society of Cardiology (2016) points to the fact that the range of indications for VAD implantation for patients with chronic heart disease will continue to change. The ISHLT Guideline (International Society for Heart and Lung Transplantation), published in 2018, calls for psychosocial care and standardized self-management skills for patients before, during, and in the long-term after VAD implantation. This is currently being implemented inconsistently in terms of structure and quality in German cardiac centers. After VAD implantation, patients and their relatives must be able to follow a complex therapeutic regimen. They need comprehensive knowledge as well as self-management skills for the safe management of everyday life in a domestic setting. These self-management capabilities include the so-called device handling (for example dealing with the technical equipment including battery replacement and controller monitoring), to perform the wound care of the driveline, to carry out anticoagulation measurements and adapted revenues of oral anticoagulant, to take further medication, to monitor vital signs (for example blood pressure, temperature) and, in the case of symptoms, to take adequate measures to prevent further complications (for example prompt information from the heart center on the onset of symptoms). In addition, lifestyle changes are an essential part of the success of long-term therapy. This requires a sufficient degree of self-management ability and mental stability. In addition, it is important to emotionally accept the dependence of a device on the heart, the changed body image, to cope with fears of (real potential) malfunctions and complications and to build up a subjective quality of life with a constant, visible and tangible companion at heart. The mental health of all those affected is considered to be in need of observation, although there is currently no reliable prevalence data on mental disorders. In a first survey in 2006, 64% had at least one psychologically / psychiatric treatment requiring diagnosis. All this shows, the challenges VAD patients have to face are complex. Thus, this study aims to provide multi-centered actual analysis of self-management capabilities as well as analyzing moderating predictors in VAD patients through standardized PRO prevalence assessment. The prevalence survey should be conducted in all outpatients (at least 3 months up to a maximum of 3 years at the VAD) in four established German cardiac centers (Freiburg, Berlin, Bad Oeynhausen, Leipzig). The study focuses on those involved in outpatient care, as they had to integrate the VAD into their daily lives after implantation and are able to report deficits, resources and needs on the basis of their experience of self-management. As an assessment instrument a standardized PRO measure was chosen to identify self-management skills and needs. Secondary PRO measures include health-related quality of life, symptoms of anxiety, depression and post-traumatic stress, as well as social support. Relevant complications (bleeding, wound infections, thromboembolic neurological events) are taken from the patient records. Based on a conservative sample size estimation inclusion of 450 patients is envisioned. The expected results may contribute to an improved assessment of the current situation in terms of self-management skills and needs for curricular training concepts and psychosocial concomitant therapy. Long-term, the study results contribute to improve the health care for long-term VAD patients. The study is planned to continue in a second and third phase to develop and test a standardized self-management care for VAD patients in Germany.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAD Patients | – | Other: Prevalence SurveyPatients with implanted ventricular assist device in the outpatient setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients implanted with a ventricular assist device in the outpatient setting of four heart centers in Germany (Freiburg, Berlin, Bad Oeynhausen and Leipzig).
Key inclusion criteria (6 listed)
- Outpatient at the respective heart center
- Living in a home environment
- On device between 3 months and 3 years
- 18 years and older
- No contraindications (e.g. cognitive, language)
Key exclusion criteria (6 listed)
- In-patient stay
- Not living in a home environment (e.g. assisted living)
- On device less than 3 months or more than 3 years
- Underage
- Contraindications (e.g. cognitive, language)
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 |
|---|---|---|
| Prevalence SurveyQuestionnaire survey on self-management | Other | VAD Patients |
Primary outcome
Self-management Skills
Time frame: October 2019 till January 2020
As an assessment instrument a standardized PRO measure was chosen to identify self-management skills and needs.
5 secondary outcomes
Health-related Quality of Life
Time frame: October 2019 till January 2020
Social Support
Time frame: October 2019 till January 2020
Symptoms of Anxiety
Time frame: October 2019 till January 2020
Symptoms of Depression
Time frame: October 2019 till January 2020
Symptoms of Posttraumatic Stress Disorder
Time frame: October 2019 till January 2020
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 6 Nov 2020.
- Derived from this study: PubMed 38170263Kugler C, Spielmann H, Albert W, Lauenroth V, Spitz-Koeberich C, Semmig-Koenze S, Staus P, Tigges-Limmer K; SELMA Study Group. Professional Employment in Patients on Ventricular Assist Device Support-A National Multicenter Survey Study. ASAIO J. 2024 May 1;70(5):348-355. doi: 10.1097/MAT.0000000000002124. Epub 2024 Jan 3.
- Derived from this study: PubMed 37991265Spielmann H, Tigges-Limmer K, Albert W, Spitz-Koberich C, Semmig-Konze S, Staus P, Herrmann-Lingen C, Sandau KE, Okeson B, Geyer S, Kugler C; Selma Study Group. Health-Related Quality of Life in Patients With Ventricular Assist Device: Psychometric Evaluation of the German Version of the Quality of Life With a Ventricular Assist Device Questionnaire. J Cardiovasc Nurs. 2024 Nov-Dec 01;39(6):571-582. doi: 10.1097/JCN.0000000000001064. Epub 2023 Nov 22.
- Derived from this study: PubMed 37837720Spielmann H, Albert W, Semmig-Konze S, Lauenroth V, Spitz-Koberich C, Staus P, Tigges-Limmer K, Kugler C; SELMA Study Group. High level of psychosocial adjustment in patients on ongoing ventricular assist device support in the years one to three after VAD implantation-A national multi-center Study. Heart Lung. 2024 Jan-Feb;63:92-97. doi: 10.1016/j.hrtlng.2023.10.003. Epub 2023 Oct 12.
- Derived from this study: PubMed 33952544Kugler C, Spielmann H, Seemann M, Lauenroth V, Wacker R, Albert W, Spitz-Koeberich C, Semmig-Koenze S, von Cube M, Tigges-Limmer K. Self-management for patients on ventricular assist device support: a national, multicentre study: protocol for a 3-phase study. BMJ Open. 2021 May 5;11(5):e044374. doi: 10.1136/bmjopen-2020-044374.
- Derived from this study: PubMed 33621837Spielmann H, Seemann M, Friedrich N, Tigges-Limmer K, Albert W, Semmig-Konze S, Spitz-Koberich C, Kugler C. Self-management with the therapeutic regimen in patients with ventricular assist device (VAD) support - a scoping review. Heart Lung. 2021 May-Jun;50(3):388-396. doi: 10.1016/j.hrtlng.2021.01.019. Epub 2021 Feb 20.
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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.
Christiane Kugler, Prof. Dr. study director
University of Freiburg
Christiane Kugler, Prof. Dr. principal investigator
University of Freiburg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Assist Device and Self-management, run by University of Freiburg at 4 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 6 inclusion and 6 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 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Self-management Skills (time frame: October 2019 till January 2020). 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 NCT04234230, which also lists 5 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 6 Nov 2020.