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

May 9, 2023 updated by: Christiane Kugler, University of Freiburg

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • German Heart Center Berlin
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79110
        • University Heart Center Freiburg • Bad Krozingen
    • Nordrhein-Westfalen
      • Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
        • Heart and Diabetes Center NRW, Bad Oeynhausen
    • Sachsen
      • Leipzig, Sachsen, Germany, 04289
        • Leipzig Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Behavioral: 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.
No Intervention: Control Group (CGr)
Participants in the control group (CGr) receive the standard follow-up procedures (care as usual).

What is the study measuring?

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)
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").
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)
Time Frame: From 2-4 days post-implant to 12 months post-implant
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)
Time Frame: From 2-4 weeks post-implant to 12 months post-implant
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)
Time Frame: From 2-4 days post-implant to 12 months post-implant
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)
Time Frame: From 2-4 days post-implant to 12 months post-implant
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)
Time Frame: From 2-4 days post-implant to 12 months post-implant
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Comorbidities 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
Relevant comorbidities (e.g. Diabetes, Hypertension, psychic comorbidities) will be taken from the medical record of the participants.
From 2-4 days post-implant to 12 months post-implant
VAD Type
Time Frame: 2-4 days post-implant
Information on implanted VAD type (HVAD, HMIII or other) will be taken from the medical record of the participants.
2-4 days post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Freiburg

Collaborators

Heart Center Leipzig - University Hospital
Heart and Diabetes Center North Rhine-Westphalia
University Heart Center Freiburg - Bad Krozingen
German Heart Center

Investigators

  • Study Director: Christiane Kugler, Prof. Dr., University of Freiburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2020

Primary Completion (Actual)

January 15, 2023

Study Completion (Actual)

January 15, 2023

Study Registration Dates

First Submitted

August 14, 2020

First Submitted That Met QC Criteria

August 25, 2020

First Posted (Actual)

August 26, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 01VSF18012 (Phase 3)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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