Clinical trial NCT04526964: Improved Self-management for Patients on Ventricular Assist Device (VAD) Support - Phase 3
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Assist Device
Psychosocial Factors
Self-management
Keywords: Ventricular Assist Device
Psychosocial Factors
Evidence-based Curriculum
Self-management
Lead sponsor: University of Freiburg
Sponsor class: OTHER
Collaborators: name: University Heart Center Freiburg - Bad Krozingen
name: Heart and Diabetes Center North Rhine-Westphalia
name: German Heart Center
name: Heart Center Leipzig - University Hospital
First posted: 2020-08-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Self-management Skills from 2-4 Weeks Post-implant (T1) to 12 Months Post-implant (T3)
timeFrame: From 2-4 weeks post-implant to 12 months post-implant
Secondary outcomes:
measure: Change in Health-related Quality of Life From 2-4 Days Post-implant (T0) to 12 Months Post-implant (T3)
timeFrame: From 2-4 days post-implant to 12 months post-implant
measure: Change in Perceived Social Support From 2-4 Weeks Post-implant (T1) to 12 Months Post-implant (T3)
timeFrame: From 2-4 weeks post-implant to 12 months post-implant
measure: Change in Symptoms of Anxiety From 2-4 Days Post-implant (T0) to 12 Months Post-implant (T3)
timeFrame: From 2-4 days post-implant to 12 months post-implant
measure: Change in Symptoms of Depression From 2-4 Days Post-implant (T0) to 12 Months Post-implant (T3)
timeFrame: From 2-4 days post-implant to 12 months post-implant
measure: Change in Adverse Event Rates From 2-4 Days Post-implant (T0) to 12 Months Post-implant (T3)
timeFrame: From 2-4 days post-implant to 12 months post-implant
Other outcomes:
measure: Change in Comorbidities From 2-4 Days Post-implant (T0) to 12 Months Post-implant (T3)
timeFrame: From 2-4 days post-implant to 12 months post-implant
measure: VAD Type
timeFrame: 2-4 days post-implant
Locations:
city: Freiburg
country: Germany
facility: University Heart Center Freiburg • Bad Krozingen
state: Baden-Württemberg
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center NRW, Bad Oeynhausen
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Leipzig Heart Center
state: Sachsen
city: Berlin
country: Germany
facility: German Heart Center Berlin
Study officials:
affiliation: University of Freiburg
name: Christiane Kugler, Prof. Dr.
role: STUDY_DIRECTOR
References:
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