Ventricular Assist DeviceSELMANCT04526964
Improved Self-management for Patients on Ventricular Assist Device (VAD) Support - Phase 3
A study testing Self-management curriculum in people with Ventricular Assist Device and Psychosocial Factors, run by University of Freiburg at 4 sites in Germany.
Trial summary
The number of patients suffering from end-stage heart disease challenges healthcare services in the western world, where an estimated 1-2% of the population suffer from this chronic condition. Ventricular assist device (VAD) implantations have become a common therapeutic strategy for those affected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Assist Device, Psychosocial Factors, Self-management
- What is being tested?
- Self-management curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 4 sitesGermany
- Study dates
- 7 Sep 2020to 15 Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable postoperative condition
- Outpatient treatment at the respective heart center
- 18 years and older
- No contraindications (e.g. Cognitive, Language)
- Signed Informed Consent
Who cannot join
- Not an outpatient at the respective heart center
- Underage
- Contraindications (e.g. Cognitive, Language)
- No signed Informed Consent
- Participation in other behavior-related studies
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Heart and Diabetes Center NRW, Bad Oeynhausen
Bad Oeynhausen, North Rhine-Westphalia, 32545
German Heart Center Berlin
Berlin, 13353
University Heart Center Freiburg • Bad Krozingen
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 3: Randomized Controlled Trial (RCT)
The number of patients suffering from end-stage heart disease challenges healthcare services in the western world, where an estimated 1-2% of the population suffer from this chronic condition. Ventricular assist device (VAD) implantations have become a common therapeutic strategy for those affected. Live with a VAD, however, is far from normal and does expose patients to multiple challenges and the need to adjust to a complex self-management. Inadequate self-management can lead to serious complications, specifically neuro-cognitive events, bleeding, and exit-site related wound infections may impair the outcome following the VAD implantation procedure.
Based on systematized literature review and a previous prevalence assessment study (ClinicalTrials.gov Identifier: NCT04234230), a modular evidence-based curriculum has been developed by a multiprofessional group of experts. This curriculum aims at improving knowledge, skills, and competencies for those affected to empower VAD patients to better self-manage their everyday life with the VAD, and to regain quality of life. This study focuses on a multi-center implementation and evaluation of the curriculum using a fully powered randomized-controlled study (RCT) design. This RCT will be conducted at four established cardiac centers throughout Germany. Participants will be assigned to either intervention or control using a 1: 1 randomization scheme. Block-randomization will be performed by a professional from the study coordinating center not being involved into the clinical care for patients. At the participating sites, the group assignment is non-blinded to the professionals involved in order to enable the intervention so be carried out adequately. Participants in the control group (CGr) receive the standard follow-up procedures (care as usual). Participants in the intervention group (IGr) receive self-management support and skills training based on the modular self-management curriculum post-implant, and during regular outpatient follow-up. The intervention lasts for 3 months followed by a 9-month follow-up per participant. Based on the power calculations the inclusion of 142 patients is anticipated.
Read the detailed description
The number of patients suffering from end-stage heart disease challenges healthcare services in the western world, where an estimated 1-2% of the population suffer from this chronic condition. Ventricular assist device (VAD) implantations have become a common therapeutic strategy for those affected. Indications include a multi-year bridging therapy (up to 10 years) and increasingly a destination therapy. The Euromacs Registry 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 for the treatment of patients with end-stage failure (NYHA classes III and IV). 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) warns that the range of indications for VAD implantation for people 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 of 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. Live with a VAD, however, is far from normal and does expose patients to multiple challenges and the need to adjust to a complex self-management. Inadequate self-management can lead to serious complications, specifically neuro-cognitive events, bleeding, and exit-site related wound infections may impair the outcome following the VAD implantation procedure.
The design for this study will be a fully-powered block-randomized trial (RCT). This RCT will be conducted at four established cardiac centers throughout Germany. Participants will be assigned to either intervention or control using a 1: 1 randomization scheme. Block-randomization will be performed by a professional from the study coordinating center not being involved into the clinical care for patients. At the participating sites, the group assignment is non-blinded to the professionals involved in order to enable the intervention so be carried out adequately. Participants in the control group (CGr) receive the standard follow-up procedures (care as usual). Participants in the intervention group (IGr) receive self-management support and skills training based on the modular self-management curriculum post-implant, and during regular outpatient follow-up. The self-management training program will be supplemented by a smartphone-based application. The smartphone application will be downloaded optionally on the patients' own smartphones, and patients will be instructed on how to use it. In the app, the study participants can receive additional information on health-related data, e.g. weight, temperature, sleep or mood. Entering health related data is absolutely voluntary. No data will be transferred to the clinical sites. The study participants can also use the app to read VAD related information only without any registration. Data entered (optional) are used only for the participants' own information overview. The intervention lasts for 3 months followed by a 9-month follow-up period per participant. Based on the power calculations the inclusion of 142 patients is anticipated.
The expected results can improve self-management, self-efficacy, and health-related quality of life for patients on VAD support. In addition, a reduction in VAD-specific complications and inpatient admission rates due to reduced complication rates can expected. The project aims to improve long-term psychosocial care through self-management support for patients on VAD support. The modular curriculum and the supporting
- Being tested
- Self-management curriculum
- Keywords
- Ventricular Assist Device, Psychosocial Factors, Evidence-based Curriculum, Self-management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management curriculumBehavioural
The Intervention starts during inpatient phase after relocation of potential study participants from the intensive care unit to normal ward and after informed consent to participate. Those subjects assigned to the CGr by randomization code receive standard care at the respective center. Subjects assigned to the IGr received, in addition to standard care, a multi-modular self-management training carried out at the respective center. The content of the self-management training should be deepened and consolidated through a supplementary app. Training is performed during inpatient post-implant phase, as well as one refresher session about six weeks after discharge during regular outpatient follow-up. The intervention lasts 3 months, plus a 9-month follow-up per subject. The content of the self-management training is based on current evidence and was written in a curriculum to achieve the highest possible standardization, taking into account the center specifics.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (IGr) | Other | Participants of the intervention group (IGr) receive self-management support and skills training based on the modular self-management curriculum during the inpatient post-implant phase, as well as one refresher session about six weeks after discharge during regular outpatient follow-up and a supplementary app. Receives: Behavioral: Self-management curriculum |
| Control Group (CGr) | No intervention | Participants in the control group (CGr) receive the standard follow-up procedures (care as usual). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-management Skills from 2-4 Weeks Post-implant (T1) to 12 Months Post-implant (T3)
Self-managment skills and needs of the participants (for example medication intake or infection prevention) measured with a self-assessment questionnaire ("SELMA questionnaire").
Measured: From 2-4 weeks post-implant to 12 months post-implant
Secondary outcomes (5)
Change in Health-related Quality of Life From 2-4 Days Post-implant (T0) to 12 Months Post-implant (T3)
The perceived health-related quality of life of the participants measured with the self-assessment questionnaire "QoL-VAD". Values range from 0 to 100 for each scale with higher values indicate better outcome.
Measured: From 2-4 days post-implant to 12 months post-implant
Change in Perceived Social Support From 2-4 Weeks Post-implant (T1) to 12 Months Post-implant (T3)
The perceived social support of the participants measured with the brief form of the "Perceived Social Support Questionnaire" (F-SozU K-14). Higher scores indicate better outcomes.
Measured: From 2-4 weeks post-implant to 12 months post-implant
Change in Symptoms of Anxiety From 2-4 Days Post-implant (T0) to 12 Months Post-implant (T3)
Symptoms of anxiety measured with the screening instrument "Hospital Anxiety and Depression Scale" (HADS). Values range from 0 to 21 for each scale with higher values indicate worse outcome.
Measured: From 2-4 days post-implant to 12 months post-implant
Change in Symptoms of Depression From 2-4 Days Post-implant (T0) to 12 Months Post-implant (T3)
Symptoms of depression measured with the screening instrument "Hospital Anxiety and Depression Scale" (HADS). Values range from 0 to 21 for each scale with higher values indicate worse outcome.
Measured: From 2-4 days post-implant to 12 months post-implant
Change in Adverse Event Rates From 2-4 Days Post-implant (T0) to 12 Months Post-implant (T3)
Potentially relevant adverse events, the number of neurocognitive events, the number of bleeding events, and the number of and exit-site related wound infections will be taken from the medical record of the participants.
Measured: From 2-4 days post-implant to 12 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start7 Sep 2020
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This RCT will be conducted at four established cardiac centers in Germany. Participants will be assigned to either intervention or control using a 1: 1 randomization scheme. Block-randomization will be performed by a professional from the study coordinating center not being involved into the clinical care for patients. The group assignment is non-blinded to the professionals involved in order to enable the intervention to be carried out adequately. Participants in the control group (CGr) receive standard follow-up procedures (care as usual). The intervention group (IGr) receive self-management support and skills training based on the modular self-management curriculum post-implant and during regular outpatient follow-up. The self-management training program will be supplemented by a smartphone-based application. The intervention lasts for 3 months followed by a 9-month follow-up period per participant. Based on power calculations the inclusion of 142 patients is anticipated.
- Masking
- None (open label)
- Enrolment
- 140 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-Westphalia, 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 Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526964
- Sponsor's protocol ID
- 01VSF18012 (Phase 3)
- Acronym
- SELMA
- Status last verified
- May 2023
- First submitted
- 14 Aug 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Feldman D, Pamboukian SV, Teuteberg JJ, Birks E, Lietz K, Moore SA, Morgan JA, Arabia F, Bauman ME, Buchholz HW, Deng M, Dickstein ML, El-Banayosy A, Elliot T, Goldstein DJ, Grady KL, Jones K, Hryniewicz K, John R, Kaan A, Kusne S, Loebe M, Massicotte MP, Moazami N, Mohacsi P, Mooney M, Nelson T, Pagani F, Perry W, Potapov EV, Eduardo Rame J, Russell SD, Sorensen EN, Sun B, Strueber M, Mangi AA, Petty MG, Rogers J; International Society for Heart and Lung Transplantation. The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: executive summary. J Heart Lung Transplant. 2013 Feb;32(2):157-87. doi: 10.1016/j.healun.2012.09.013. No abstract available.
PubMed 23352391de By TMMH, Mohacsi P, Gahl B, Zittermann A, Krabatsch T, Gustafsson F, Leprince P, Meyns B, Netuka I, Caliskan K, Castedo E, Musumeci F, Vincentelli A, Hetzer R, Gummert J; EUROMACS members. The European Registry for Patients with Mechanical Circulatory Support (EUROMACS) of the European Association for Cardio-Thoracic Surgery (EACTS): second report. Eur J Cardiothorac Surg. 2018 Feb 1;53(2):309-316. doi: 10.1093/ejcts/ezx320.
PubMed 29029117de By TM, Mohacsi P, Gummert J, Bushnaq H, Krabatsch T, Gustafsson F, Leprince P, Martinelli L, Meyns B, Morshuis M, Netuka I, Potapov E, Zittermann A, Delmo Walter EM, Hetzer R; EUROMACS members. The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): first annual report. Eur J Cardiothorac Surg. 2015 May;47(5):770-6; discussion 776-7. doi: 10.1093/ejcts/ezv096. Epub 2015 Mar 27.
PubMed 25820161Beckmann A, Funkat AK, Lewandowski J, Frie M, Ernst M, Hekmat K, Schiller W, Gummert JF, Cremer JT. Cardiac Surgery in Germany during 2014: A Report on Behalf of the German Society for Thoracic and Cardiovascular Surgery. Thorac Cardiovasc Surg. 2015 Jun;63(4):258-69. doi: 10.1055/s-0035-1551676. Epub 2015 May 26.
PubMed 26011675Reichenspurner H. Geleitwort zu "Rehabilitationsstandards fur die Anschlussheilbehandlung und allgemeine Rehabilitation fur Patienten mit einem Herzunterstutzungssystem (VAD Ventricular Assist Device)". Clin Res Cardiol Suppl. 2016 Mar;11 Suppl 1:1. doi: 10.1007/s11789-016-0080-x. No abstract available. German.
PubMed 26882904Dew MA, DiMartini AF, Dobbels F, Grady KL, Jowsey-Gregoire SG, Kaan A, Kendall K, Young QR, Abbey SE, Butt Z, Crone CC, De Geest S, Doligalski CT, Kugler C, McDonald L, Ohler L, Painter L, Petty MG, Robson D, Schloglhofer T, Schneekloth TD, Singer JP, Smith PJ, Spaderna H, Teuteberg JJ, Yusen RD, Zimbrean PC. The 2018 ISHLT/APM/AST/ICCAC/STSW recommendations for the psychosocial evaluation of adult cardiothoracic transplant candidates and candidates for long-term mechanical circulatory support. J Heart Lung Transplant. 2018 Jul;37(7):803-823. doi: 10.1016/j.healun.2018.03.005. Epub 2018 Apr 27.
PubMed 29709440Kato N, Jaarsma T, Ben Gal T. Learning self-care after left ventricular assist device implantation. Curr Heart Fail Rep. 2014 Sep;11(3):290-8. doi: 10.1007/s11897-014-0201-0.
PubMed 24831883Eshelman AK, Mason S, Nemeh H, Williams C. LVAD destination therapy: applying what we know about psychiatric evaluation and management from cardiac failure and transplant. Heart Fail Rev. 2009 Mar;14(1):21-8. doi: 10.1007/s10741-007-9075-5. Epub 2008 Jan 24.
PubMed 18214674Kugler C, Bara C, von Waldthausen T, Einhorn I, Haastert B, Fegbeutel C, Haverich A. Association of depression symptoms with quality of life and chronic artery vasculopathy: a cross-sectional study in heart transplant patients. J Psychosom Res. 2014 Aug;77(2):128-34. doi: 10.1016/j.jpsychores.2014.06.007. Epub 2014 Jun 23.
PubMed 25077854Kugler C, Meng M, Rehn E, Morshuis M, Gummert JF, Tigges-Limmer K. Sexual activity in patients with left ventricular assist devices and their partners: impact of the device on quality of life, anxiety and depression. Eur J Cardiothorac Surg. 2018 Apr 1;53(4):799-806. doi: 10.1093/ejcts/ezx426.
PubMed 29211843Caro MA, Rosenthal JL, Kendall K, Pozuelo L, Funk MC. What the Psychiatrist Needs to Know About Ventricular Assist Devices: A Comprehensive Review. Psychosomatics. 2016 May-Jun;57(3):229-37. doi: 10.1016/j.psym.2016.01.002. Epub 2016 Jan 12.
PubMed 27005723Kugler 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 33952544
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. 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 3: Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT04526964
- Acronym / sponsor ID
- SELMA / 01VSF18012 (Phase 3)
- Keywords
- Ventricular Assist Device, Psychosocial Factors, Evidence-based Curriculum, Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of FreiburgUniversity, hospital or other
- Collaborators
- University Heart Center Freiburg - Bad Krozingen, Heart and Diabetes Center North Rhine-Westphalia, German Heart Center, Heart Center Leipzig - University Hospital
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 26 Aug 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 suffering from end-stage heart disease challenges healthcare services in the western world, where an estimated 1-2% of the population suffer from this chronic condition. Ventricular assist device (VAD) implantations have become a common therapeutic strategy for those affected. Live with a VAD, however, is far from normal and does expose patients to multiple challenges and the need to adjust to a complex self-management. Inadequate self-management can lead to serious complications, specifically neuro-cognitive events, bleeding, and exit-site related wound infections may impair the outcome following the VAD implantation procedure.
Based on systematized literature review and a previous prevalence assessment study (ClinicalTrials.gov Identifier: NCT04234230), a modular evidence-based curriculum has been developed by a multiprofessional group of experts. This curriculum aims at improving knowledge, skills, and competencies for those affected to empower VAD patients to better self-manage their everyday life with the VAD, and to regain quality of life. This study focuses on a multi-center implementation and evaluation of the curriculum using a fully powered randomized-controlled study (RCT) design. This RCT will be conducted at four established cardiac centers throughout Germany. Participants will be assigned to either intervention or control using a 1: 1 randomization scheme. Block-randomization will be performed by a professional from the study coordinating center not being involved into the clinical care for patients. At the participating sites, the group assignment is non-blinded to the professionals involved in order to enable the intervention so be carried out adequately. Participants in the control group (CGr) receive the standard follow-up procedures (care as usual). Participants in the intervention group (IGr) receive self-management support and skills training based on the modular self-management curriculum post-implant, and during regular outpatient follow-up. The intervention lasts for 3 months followed by a 9-month follow-up per participant. Based on the power calculations the inclusion of 142 patients is anticipated.
Detailed description
The number of patients suffering from end-stage heart disease challenges healthcare services in the western world, where an estimated 1-2% of the population suffer from this chronic condition. Ventricular assist device (VAD) implantations have become a common therapeutic strategy for those affected. Indications include a multi-year bridging therapy (up to 10 years) and increasingly a destination therapy. The Euromacs Registry 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 for the treatment of patients with end-stage failure (NYHA classes III and IV). 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) warns that the range of indications for VAD implantation for people 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 of 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. Live with a VAD, however, is far from normal and does expose patients to multiple challenges and the need to adjust to a complex self-management. Inadequate self-management can lead to serious complications, specifically neuro-cognitive events, bleeding, and exit-site related wound infections may impair the outcome following the VAD implantation procedure.
The design for this study will be a fully-powered block-randomized trial (RCT). This RCT will be conducted at four established cardiac centers throughout Germany. Participants will be assigned to either intervention or control using a 1: 1 randomization scheme. Block-randomization will be performed by a professional from the study coordinating center not being involved into the clinical care for patients. At the participating sites, the group assignment is non-blinded to the professionals involved in order to enable the intervention so be carried out adequately. Participants in the control group (CGr) receive the standard follow-up procedures (care as usual). Participants in the intervention group (IGr) receive self-management support and skills training based on the modular self-management curriculum post-implant, and during regular outpatient follow-up. The self-management training program will be supplemented by a smartphone-based application. The smartphone application will be downloaded optionally on the patients' own smartphones, and patients will be instructed on how to use it. In the app, the study participants can receive additional information on health-related data, e.g. weight, temperature, sleep or mood. Entering health related data is absolutely voluntary. No data will be transferred to the clinical sites. The study participants can also use the app to read VAD related information only without any registration. Data entered (optional) are used only for the participants' own information overview. The intervention lasts for 3 months followed by a 9-month follow-up period per participant. Based on the power calculations the inclusion of 142 patients is anticipated.
The expected results can improve self-management, self-efficacy, and health-related quality of life for patients on VAD support. In addition, a reduction in VAD-specific complications and inpatient admission rates due to reduced complication rates can expected. The project aims to improve long-term psychosocial care through self-management support for patients on VAD support. The modular curriculum and the supporting
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This RCT will be conducted at four established cardiac centers in Germany. Participants will be assigned to either intervention or control using a 1: 1 randomization scheme. Block-randomization will be performed by a professional from the study coordinating center not being involved into the clinical care for patients. The group assignment is non-blinded to the professionals involved in order to enable the intervention to be carried out adequately. Participants in the control group (CGr) receive standard follow-up procedures (care as usual). The intervention group (IGr) receive self-management support and skills training based on the modular self-management curriculum post-implant and during regular outpatient follow-up. The self-management training program will be supplemented by a smartphone-based application. The intervention lasts for 3 months followed by a 9-month follow-up period per participant. Based on power calculations the inclusion of 142 patients is anticipated.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (IGr) | Other | Behavioral: Self-management curriculumParticipants of the intervention group (IGr) receive self-management support and skills training based on the modular self-management curriculum during the inpatient post-implant phase, as well as one refresher session about six weeks after discharge during regular outpatient follow-up and a supplementary app. |
| Control Group (CGr) | No intervention | –Participants in the control group (CGr) receive the standard follow-up procedures (care as usual). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stable postoperative condition
- Outpatient treatment at the respective heart center
- 18 years and older
- No contraindications (e.g. Cognitive, Language)
- Signed Informed Consent
Key exclusion criteria (5 listed)
- Not an outpatient at the respective heart center
- Underage
- Contraindications (e.g. Cognitive, Language)
- No signed Informed Consent
- Participation in other behavior-related studies
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 |
|---|---|---|
| Self-management curriculumThe Intervention starts during inpatient phase after relocation of potential study participants from the intensive care unit to normal ward and after informed consent to participate. Those subjects assigned to the CGr by randomization code receive standard care at the respective center. Subjects assigned to the IGr received, in addition to standard care, a multi-modular self-management training carried out at the respective center. The content of the self-management training should be deepened and consolidated through a supplementary app. Training is performed during inpatient post-implant phase, as well as one refresher session about six weeks after discharge during regular outpatient follow-up. The intervention lasts 3 months, plus a 9-month follow-up per subject. The content of the self-management training is based on current evidence and was written in a curriculum to achieve the highest possible standardization, taking into account the center specifics. | Behavioural | Intervention Group (IGr) |
Primary outcome
Change in Self-management Skills from 2-4 Weeks Post-implant (T1) to 12 Months Post-implant (T3)
Time frame: From 2-4 weeks post-implant to 12 months post-implant
Self-managment skills and needs of the participants (for example medication intake or infection prevention) measured with a self-assessment questionnaire ("SELMA questionnaire").
5 secondary outcomes
Change in Health-related Quality of Life From 2-4 Days Post-implant (T0) to 12 Months Post-implant (T3)
Time frame: From 2-4 days post-implant to 12 months post-implant
Change in Perceived Social Support From 2-4 Weeks Post-implant (T1) to 12 Months Post-implant (T3)
Time frame: From 2-4 weeks post-implant to 12 months post-implant
Change in Symptoms of Anxiety From 2-4 Days Post-implant (T0) to 12 Months Post-implant (T3)
Time frame: From 2-4 days post-implant to 12 months post-implant
Change in Symptoms of Depression From 2-4 Days Post-implant (T0) to 12 Months Post-implant (T3)
Time frame: From 2-4 days post-implant to 12 months post-implant
Change in Adverse Event Rates From 2-4 Days Post-implant (T0) to 12 Months Post-implant (T3)
Time frame: From 2-4 days post-implant to 12 months post-implant
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 10 May 2023.
- Background: PubMed 23352391Feldman D, Pamboukian SV, Teuteberg JJ, Birks E, Lietz K, Moore SA, Morgan JA, Arabia F, Bauman ME, Buchholz HW, Deng M, Dickstein ML, El-Banayosy A, Elliot T, Goldstein DJ, Grady KL, Jones K, Hryniewicz K, John R, Kaan A, Kusne S, Loebe M, Massicotte MP, Moazami N, Mohacsi P, Mooney M, Nelson T, Pagani F, Perry W, Potapov EV, Eduardo Rame J, Russell SD, Sorensen EN, Sun B, Strueber M, Mangi AA, Petty MG, Rogers J; International Society for Heart and Lung Transplantation. The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: executive summary. J Heart Lung Transplant. 2013 Feb;32(2):157-87. doi: 10.1016/j.healun.2012.09.013. No abstract available.
- Background: PubMed 29029117de By TMMH, Mohacsi P, Gahl B, Zittermann A, Krabatsch T, Gustafsson F, Leprince P, Meyns B, Netuka I, Caliskan K, Castedo E, Musumeci F, Vincentelli A, Hetzer R, Gummert J; EUROMACS members. The European Registry for Patients with Mechanical Circulatory Support (EUROMACS) of the European Association for Cardio-Thoracic Surgery (EACTS): second report. Eur J Cardiothorac Surg. 2018 Feb 1;53(2):309-316. doi: 10.1093/ejcts/ezx320.
- Background: PubMed 25820161de By TM, Mohacsi P, Gummert J, Bushnaq H, Krabatsch T, Gustafsson F, Leprince P, Martinelli L, Meyns B, Morshuis M, Netuka I, Potapov E, Zittermann A, Delmo Walter EM, Hetzer R; EUROMACS members. The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): first annual report. Eur J Cardiothorac Surg. 2015 May;47(5):770-6; discussion 776-7. doi: 10.1093/ejcts/ezv096. Epub 2015 Mar 27.
- Background: PubMed 26011675Beckmann A, Funkat AK, Lewandowski J, Frie M, Ernst M, Hekmat K, Schiller W, Gummert JF, Cremer JT. Cardiac Surgery in Germany during 2014: A Report on Behalf of the German Society for Thoracic and Cardiovascular Surgery. Thorac Cardiovasc Surg. 2015 Jun;63(4):258-69. doi: 10.1055/s-0035-1551676. Epub 2015 May 26.
- Background: PubMed 26882904Reichenspurner H. Geleitwort zu "Rehabilitationsstandards fur die Anschlussheilbehandlung und allgemeine Rehabilitation fur Patienten mit einem Herzunterstutzungssystem (VAD Ventricular Assist Device)". Clin Res Cardiol Suppl. 2016 Mar;11 Suppl 1:1. doi: 10.1007/s11789-016-0080-x. No abstract available. German.
- Background: PubMed 29709440Dew MA, DiMartini AF, Dobbels F, Grady KL, Jowsey-Gregoire SG, Kaan A, Kendall K, Young QR, Abbey SE, Butt Z, Crone CC, De Geest S, Doligalski CT, Kugler C, McDonald L, Ohler L, Painter L, Petty MG, Robson D, Schloglhofer T, Schneekloth TD, Singer JP, Smith PJ, Spaderna H, Teuteberg JJ, Yusen RD, Zimbrean PC. The 2018 ISHLT/APM/AST/ICCAC/STSW recommendations for the psychosocial evaluation of adult cardiothoracic transplant candidates and candidates for long-term mechanical circulatory support. J Heart Lung Transplant. 2018 Jul;37(7):803-823. doi: 10.1016/j.healun.2018.03.005. Epub 2018 Apr 27.
- Background: PubMed 24831883Kato N, Jaarsma T, Ben Gal T. Learning self-care after left ventricular assist device implantation. Curr Heart Fail Rep. 2014 Sep;11(3):290-8. doi: 10.1007/s11897-014-0201-0.
- Background: PubMed 18214674Eshelman AK, Mason S, Nemeh H, Williams C. LVAD destination therapy: applying what we know about psychiatric evaluation and management from cardiac failure and transplant. Heart Fail Rev. 2009 Mar;14(1):21-8. doi: 10.1007/s10741-007-9075-5. Epub 2008 Jan 24.
- Background: PubMed 25077854Kugler C, Bara C, von Waldthausen T, Einhorn I, Haastert B, Fegbeutel C, Haverich A. Association of depression symptoms with quality of life and chronic artery vasculopathy: a cross-sectional study in heart transplant patients. J Psychosom Res. 2014 Aug;77(2):128-34. doi: 10.1016/j.jpsychores.2014.06.007. Epub 2014 Jun 23.
- Background: PubMed 29211843Kugler C, Meng M, Rehn E, Morshuis M, Gummert JF, Tigges-Limmer K. Sexual activity in patients with left ventricular assist devices and their partners: impact of the device on quality of life, anxiety and depression. Eur J Cardiothorac Surg. 2018 Apr 1;53(4):799-806. doi: 10.1093/ejcts/ezx426.
- Background: PubMed 27005723Caro MA, Rosenthal JL, Kendall K, Pozuelo L, Funk MC. What the Psychiatrist Needs to Know About Ventricular Assist Devices: A Comprehensive Review. Psychosomatics. 2016 May-Jun;57(3):229-37. doi: 10.1016/j.psym.2016.01.002. Epub 2016 Jan 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.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management curriculum in people with Ventricular Assist Device and Psychosocial Factors, 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 5 inclusion and 5 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 10 May 2023. 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?
Change in Self-management Skills from 2-4 Weeks Post-implant (T1) to 12 Months Post-implant (T3) (time frame: From 2-4 weeks post-implant to 12 months post-implant). 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 NCT04526964, which also lists 12 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 10 May 2023.