Pilot Study of Massage Therapy to Improve Self Efficacy in Patients With Left-ventricular Device

Advanced Heart Failure Clinical Trial

Official title:

Pilot Study of Massage Therapy to Improve Selfefficacy in Patients With Left-ventricular Device

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04851236
• Other study ID #: 00000591
• Status: Suspended
• Phase: Early Phase 1
• Start date: July 1, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2021
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To collect and compare pilot data on the impact of a massage therapy intervention against usual care on self-efficacy measures for patients with advanced heart failure immediately discharged from hospital following left-ventricular assist device (LVAD) implantation.

Description:

The investigators project is a randomized controlled pilot study that will take place at MedStar Washington Hospital Center (MWHC), a 912-bed academic medical center in Washington, D.C. MedStar Washington Hospital Center's patient population is predominantly African American (66%); and the majority live in low-income areas of the District. Over 20% are from the District's two most underserved areas -- Wards 7 and 8. Nearly 50% of the patients rely on public insurance as their primary form of insurance.

After consenting to participate, in addition to usual advanced heart failure medical therapy, 74 patients will be randomized with a 1:1 ratio to either a massage therapy experiment group or a usual care control group. Subjects randomized to the massage therapy arm will receive massages during post LVAD implant follow-up visits in the Advanced Heart Failure clinic at predetermined intervals: every week for 4 consecutive weeks, then every other week for 4 consecutive weeks. The investigators chose these intervals for two reasons: first, current massage therapy research indicates that massages administered every week or two weeks may lead to successful clinical outcomes (CITE); second, these specific intervals coincide with predetermined LVAD clinic visits for this patient group, facilitating subject participation and decreasing extra clinic visits just for research purposes. Since this study is designed to coincide with predetermined LVAD follow-up visits, the usual care control group will also be making LVAD clinic visits at the same intervals: every week for 4 consecutive weeks, then every other week for 4 consecutive weeks. After study completion, each subject randomized to usual care will be offered a massage, if interested. The investigators believe this sample size is easily achievable given current MHVI annual LVAD implants (see above). Because the study will take place during scheduled LVAD clinic visits, the investigators expect a very high study completion rate.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 74
• Est. completion date: December 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• over 18

• LVAD implantation during their most recent hospital admission

Exclusion Criteria:

• incapacitated

• non-English speaking

• on negative-pressure isolation

• have an unstable spine

• low platelets (<10,000/µL)

• or have received a massage in the last 30 days

Related Conditions & MeSH terms

• Advanced Heart Failure
• Heart Failure

Intervention

Other:
• Massage
Massage administered at regular intervals.

Locations

Country	Name	City	State
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Medstar Health Research Institute	American Massage Therapy Foundation, Massage Therapy Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life - efficacy for managing chronic disease 6-item scale	Main Outcome Measures will be change in score from baseline to study completion of Self-Efficacy for Managing Chronic Disease 6-item Scale.	1 year
Secondary	Quality of Life - Coping Orientation to Problems Experienced (COPE) Inventory	Secondary outcomes are pre-post change in score of Brief COPE Inventory (subjects randomized to intervention arm).	1 year
Secondary	Quality of Life - National Comprehensive Cancer Network Distress Thermometer	Secondary outcomes are pre-post change in score of NCCN Distress Thermometer.	1 year
Secondary	Quality of Life - McGill Quality of Life Scale	Secondary outcomes are pre-post change in score of McGill Quality of Life Scale	1 year