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

NCT04526964 | Completed DMC

• 1 other identifier: 01VSF18012 (Phase 3)
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 4

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.

Conditions

Ventricular Assist Device; Psychosocial Factors; Self-management

Keywords

Ventricular Assist Device; Psychosocial Factors; Evidence-based Curriculum; Self-management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Health-related Quality of Life From 2-4 Days Post-implant (T0) to 12 Months Post-implant (T3)

  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)

  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)

  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)

  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)

  From 2-4 days post-implant to 12 months post-implant

Other Outcomes (2)

• Change in Comorbidities From 2-4 Days Post-implant (T0) to 12 Months Post-implant (T3)

  From 2-4 days post-implant to 12 months post-implant

• VAD Type

  2-4 days post-implant

Study Arms (2)

Intervention Group (IGr)

OTHER

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

Control Group (CGr)

NO INTERVENTION

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

Interventions

Self-management curriculum 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.

Intervention Group (IGr)

Eligibility Criteria

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

You may qualify if:

• Stable postoperative condition
• Outpatient treatment at the respective heart center
• years and older
• No contraindications (e.g. Cognitive, Language)
• Signed Informed Consent

You may not qualify if:

• Not an outpatient at the respective heart center
• Underage
• Contraindications (e.g. Cognitive, Language)
• No signed Informed Consent
• Participation in other behavior-related studies

Sponsors & Collaborators

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

Study Sites (4)

University Heart Center Freiburg • Bad Krozingen

Freiburg im Breisgau, Baden-Wurttemberg, 79110, Germany

Location

Heart and Diabetes Center NRW, Bad Oeynhausen

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Leipzig Heart Center

Leipzig, Saxony, 04289, Germany

Location

German Heart Center Berlin

Berlin, 13353, Germany

Location

Related Publications (12)

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  PMID: 23352391 BACKGROUND

• de By TMMH, Mohacsi P, Gahl B, Zittermann A, Krabatsch T, Gustafsson F, Leprince P, Meyns B, Netuka I, Caliskan K, Castedo E, Musumeci F, Vincentelli A, Hetzer R, Gummert J; EUROMACS members. The European Registry for Patients with Mechanical Circulatory Support (EUROMACS) of the European Association for Cardio-Thoracic Surgery (EACTS): second report. Eur J Cardiothorac Surg. 2018 Feb 1;53(2):309-316. doi: 10.1093/ejcts/ezx320.

  PMID: 29029117 BACKGROUND

• de By TM, Mohacsi P, Gummert J, Bushnaq H, Krabatsch T, Gustafsson F, Leprince P, Martinelli L, Meyns B, Morshuis M, Netuka I, Potapov E, Zittermann A, Delmo Walter EM, Hetzer R; EUROMACS members. The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): first annual report. Eur J Cardiothorac Surg. 2015 May;47(5):770-6; discussion 776-7. doi: 10.1093/ejcts/ezv096. Epub 2015 Mar 27.

  PMID: 25820161 BACKGROUND

• Beckmann A, Funkat AK, Lewandowski J, Frie M, Ernst M, Hekmat K, Schiller W, Gummert JF, Cremer JT. Cardiac Surgery in Germany during 2014: A Report on Behalf of the German Society for Thoracic and Cardiovascular Surgery. Thorac Cardiovasc Surg. 2015 Jun;63(4):258-69. doi: 10.1055/s-0035-1551676. Epub 2015 May 26.

  PMID: 26011675 BACKGROUND

• Reichenspurner H. Geleitwort zu "Rehabilitationsstandards fur die Anschlussheilbehandlung und allgemeine Rehabilitation fur Patienten mit einem Herzunterstutzungssystem (VAD Ventricular Assist Device)". Clin Res Cardiol Suppl. 2016 Mar;11 Suppl 1:1. doi: 10.1007/s11789-016-0080-x. No abstract available. German.

  PMID: 26882904 BACKGROUND

• Dew MA, DiMartini AF, Dobbels F, Grady KL, Jowsey-Gregoire SG, Kaan A, Kendall K, Young QR, Abbey SE, Butt Z, Crone CC, De Geest S, Doligalski CT, Kugler C, McDonald L, Ohler L, Painter L, Petty MG, Robson D, Schloglhofer T, Schneekloth TD, Singer JP, Smith PJ, Spaderna H, Teuteberg JJ, Yusen RD, Zimbrean PC. The 2018 ISHLT/APM/AST/ICCAC/STSW recommendations for the psychosocial evaluation of adult cardiothoracic transplant candidates and candidates for long-term mechanical circulatory support. J Heart Lung Transplant. 2018 Jul;37(7):803-823. doi: 10.1016/j.healun.2018.03.005. Epub 2018 Apr 27.

  PMID: 29709440 BACKGROUND

• Kato N, Jaarsma T, Ben Gal T. Learning self-care after left ventricular assist device implantation. Curr Heart Fail Rep. 2014 Sep;11(3):290-8. doi: 10.1007/s11897-014-0201-0.

  PMID: 24831883 BACKGROUND

• Eshelman AK, Mason S, Nemeh H, Williams C. LVAD destination therapy: applying what we know about psychiatric evaluation and management from cardiac failure and transplant. Heart Fail Rev. 2009 Mar;14(1):21-8. doi: 10.1007/s10741-007-9075-5. Epub 2008 Jan 24.

  PMID: 18214674 BACKGROUND

• Kugler C, Bara C, von Waldthausen T, Einhorn I, Haastert B, Fegbeutel C, Haverich A. Association of depression symptoms with quality of life and chronic artery vasculopathy: a cross-sectional study in heart transplant patients. J Psychosom Res. 2014 Aug;77(2):128-34. doi: 10.1016/j.jpsychores.2014.06.007. Epub 2014 Jun 23.

  PMID: 25077854 BACKGROUND

• Kugler C, Meng M, Rehn E, Morshuis M, Gummert JF, Tigges-Limmer K. Sexual activity in patients with left ventricular assist devices and their partners: impact of the device on quality of life, anxiety and depression. Eur J Cardiothorac Surg. 2018 Apr 1;53(4):799-806. doi: 10.1093/ejcts/ezx426.

  PMID: 29211843 BACKGROUND

• Caro MA, Rosenthal JL, Kendall K, Pozuelo L, Funk MC. What the Psychiatrist Needs to Know About Ventricular Assist Devices: A Comprehensive Review. Psychosomatics. 2016 May-Jun;57(3):229-37. doi: 10.1016/j.psym.2016.01.002. Epub 2016 Jan 12.

  PMID: 27005723 BACKGROUND

• 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

Study Officials

• Christiane Kugler, Prof. Dr.

  University of Freiburg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor. rer. biol. hum.

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 26, 2020
• Study Start: September 7, 2020
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

DE (4)