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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04851236
Other study ID # 00000591
Secondary ID
Status Suspended
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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