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

NCT04234230 | Completed DMC

• 1 other identifier: 01VSF18012
• Study Type: observational
• Target: 393
• Locations: 1 country
• Sites: 4

Brief Summary

The number of patients with end-stage heart disease requiring the implantation of ventricular assist devices (VAD) is steadily increasing. Living with a VAD exposes the patients to multiple challenges and the need to learn complex self-management skills. Inadequate self-management can lead to serious complications (e.g. bleeding or wound infections) and impair the psychosocial outcome. This study aims to provide multi-centered actual analysis of self-management capabilities as well as analyzing moderating predictors in VAD patients through standardized prevalence assessment. Using a cross-sectional design, this prevalence study will be conducted at four established German heartcenters (Freiburg, Berlin, Bad Oeynhausen, Leipzig). VAD-patients are questioned about their self-management skills using standardized Patient-reported outcome (PRO) measures. Secondary PRO measures include health-related quality of life, symptoms of anxiety and depression, post-traumatic stress symptoms, social support, and changed body-image. Relevant complications (bleeding, wound infections, thromboembolic neurological events) are taken from the patient records. Based on a conservative sample size estimation inclusion of 450 patients is envisioned. The expected results may contribute to an improved assessment of the current situation in terms of self-management skills and needs for curricular training concepts and psychosocial concomitant therapy. Long-term, the study results contribute to improve the health care for long-term VAD patients.

Conditions

Ventricular Assist Device; Self-management; Psychological Factors

Keywords

Ventricular Assist Device; Self-management; Psychosocial Factors

Outcome Measures

Primary Outcomes (1)

• Self-management Skills

  As an assessment instrument a standardized PRO measure was chosen to identify self-management skills and needs.

  October 2019 till January 2020

Secondary Outcomes (5)

• Health-related Quality of Life

  October 2019 till January 2020

• Social Support

  October 2019 till January 2020

• Symptoms of Anxiety

  October 2019 till January 2020

• Symptoms of Depression

  October 2019 till January 2020

• Symptoms of Posttraumatic Stress Disorder

  October 2019 till January 2020

Other Outcomes (4)

• Comorbidities

  October 2019 till January 2020

• VAD Type

  October 2019 till January 2020

• New York Heart Association (NYHA) classification

  October 2019 till January 2020

Study Arms (1)

VAD Patients

Patients with implanted ventricular assist device in the outpatient setting

Other: Prevalence Survey

Interventions

Prevalence Survey OTHER

Questionnaire survey on self-management

VAD Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients implanted with a ventricular assist device in the outpatient setting of four heart centers in Germany (Freiburg, Berlin, Bad Oeynhausen and Leipzig).

You may qualify if:

• Outpatient at the respective heart center
• Living in a home environment
• On device between 3 months and 3 years
• years and older
• No contraindications (e.g. cognitive, language)
• Signed Informed Consent

You may not qualify if:

• In-patient stay
• Not living in a home environment (e.g. assisted living)
• On device less than 3 months or more than 3 years
• Underage
• Contraindications (e.g. cognitive, language)
• No signed Informed Consent

Sponsors & Collaborators

• University of Freiburg: lead
• University Heart Center Freiburg - Bad Krozingen: collaborator
• Heart and Diabetes Center North-Rhine Westfalia: collaborator
• German Heart Center: collaborator
• Heart Center Leipzig - University Hospital: collaborator

Study Sites (4)

University Heart Center Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79110, Germany

Location

Heart and Diabetes Center North Rhine-Westphalia

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Leipzig Heart Center

Leipzig, Saxony, 04289, Germany

Location

German Heart Center

Berlin, 13353, Germany

Location

Related Publications (5)

• Kugler C, Spielmann H, Albert W, Lauenroth V, Spitz-Koeberich C, Semmig-Koenze S, Staus P, Tigges-Limmer K; SELMA Study Group. Professional Employment in Patients on Ventricular Assist Device Support-A National Multicenter Survey Study. ASAIO J. 2024 May 1;70(5):348-355. doi: 10.1097/MAT.0000000000002124. Epub 2024 Jan 3.

  PMID: 38170263 DERIVED

• Spielmann H, Tigges-Limmer K, Albert W, Spitz-Koberich C, Semmig-Konze S, Staus P, Herrmann-Lingen C, Sandau KE, Okeson B, Geyer S, Kugler C; Selma Study Group. Health-Related Quality of Life in Patients With Ventricular Assist Device: Psychometric Evaluation of the German Version of the Quality of Life With a Ventricular Assist Device Questionnaire. J Cardiovasc Nurs. 2024 Nov-Dec 01;39(6):571-582. doi: 10.1097/JCN.0000000000001064. Epub 2023 Nov 22.

  PMID: 37991265 DERIVED

• Spielmann H, Albert W, Semmig-Konze S, Lauenroth V, Spitz-Koberich C, Staus P, Tigges-Limmer K, Kugler C; SELMA Study Group. High level of psychosocial adjustment in patients on ongoing ventricular assist device support in the years one to three after VAD implantation-A national multi-center Study. Heart Lung. 2024 Jan-Feb;63:92-97. doi: 10.1016/j.hrtlng.2023.10.003. Epub 2023 Oct 12.

  PMID: 37837720 DERIVED

• Kugler 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.

  PMID: 33952544 DERIVED

• Spielmann H, Seemann M, Friedrich N, Tigges-Limmer K, Albert W, Semmig-Konze S, Spitz-Koberich C, Kugler C. Self-management with the therapeutic regimen in patients with ventricular assist device (VAD) support - a scoping review. Heart Lung. 2021 May-Jun;50(3):388-396. doi: 10.1016/j.hrtlng.2021.01.019. Epub 2021 Feb 20.

  PMID: 33621837 DERIVED

MeSH Terms

Interventions

Contraceptive Prevalence Surveys

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Christiane Kugler, Prof. Dr.

  University of Freiburg

  STUDY DIRECTOR

• Christiane Kugler, Prof. Dr.

  University of Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor. rer. biol. hum.

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: January 21, 2020
• Study Start: October 1, 2019
• Primary Completion: August 31, 2020
• Study Completion: September 30, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

DE (4)