Improved Self-management for Patients on Ventricular Assist Device (VAD) Support - Phase 3

Study Overview
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Brief Summary
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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
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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

Official Title
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Improved Health Care for People With Chronic Heart Disease and Implanted Cardiac Support Through Curricular Self-management - Phase 3: Randomized Controlled Trial (RCT)

Conditions
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Psychosocial Factors, Ventricular Assist Device, Self-management

Intervention / Treatment
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* Behavioral: Self-management curriculum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable postoperative condition Outpatient treatment at the respective heart center 18 years and older No contraindications (e.g. Cognitive, Language) Signed Informed Consent Exclusion Criteria: Not an outpatient at the respective heart center Underage Contraindications (e.g. Cognitive, Language) No signed Informed Consent Participation in other behavior-related studies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention Group (IGr)<br>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. | Behavioral: Self-management curriculum<br>* 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.<br>|
| No Intervention: Control Group (CGr)<br>Participants in the control group (CGr) receive the standard follow-up procedures (care as usual). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | From 2-4 weeks post-implant to 12 months post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | From 2-4 days post-implant to 12 months post-implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventricular Assist Device, Psychosocial Factors, Evidence-based Curriculum, Self-management