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

NCT ID: NCT04526964

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-07
• Study Completion Date: 2023-01-15

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

Conditions

Ventricular Assist Device; Psychosocial Factors; Self-management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group (IGr)

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.

Group Type: OTHER

Self-management curriculum

Intervention Type: BEHAVIORAL

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.

Control Group (CGr)

Participants in the control group (CGr) receive the standard follow-up procedures (care as usual).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Self-management curriculum

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Heart Center Freiburg - Bad Krozingen

OTHER

Sponsor Role: collaborator

Heart and Diabetes Center North Rhine-Westphalia

OTHER

Sponsor Role: collaborator

German Heart Center

OTHER

Sponsor Role: collaborator

Heart Center Leipzig - University Hospital

OTHER

Sponsor Role: collaborator

University of Freiburg

OTHER

Sponsor Role: lead

Responsible Party

Christiane Kugler

Professor Doctor. rer. biol. hum.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christiane Kugler, Prof. Dr.

Role: STUDY_DIRECTOR

University of Freiburg

Locations

University Heart Center Freiburg • Bad Krozingen

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Heart and Diabetes Center NRW, Bad Oeynhausen

Bad Oeynhausen, North Rhine-Westphalia, Germany

Leipzig Heart Center

Leipzig, Saxony, Germany

German Heart Center Berlin

Berlin, , Germany

Countries

Germany

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Other Identifiers

01VSF18012 (Phase 3)

Identifier Type: -

Identifier Source: org_study_id