Massage Therapy for Self-efficacy in LVAD Recipients

NCT04018508 | Terminated

• 1 other identifier: STUDY00000591
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study evaluates the role of massage therapy to improve self-efficacy in patients with advanced heart failure who have recently received a left-ventricular assist device. In addition to usual care, half of the volunteer patients will receive a massage at regular clinic visits and half will not receive any massage.

Conditions

Heart Failure

Keywords

left ventricular assist device; massage; coping; self efficacy

Outcome Measures

Primary Outcomes (1)

• Change in Self-Efficacy for Managing Chronic Disease 6-item Scale from Baseline to Repeat Visits

  The Self-Efficacy for Managing Chronic Disease 6-item Scale is a psychometric scale that asks the subject 6 questions regarding confidence managing aspects of the chronic illness (fatigue, physical discomfort, emotional distress, non-pain symptoms, medication adherence, completing assigned health care related tasks). Subjects respond to each question on a Likert scale from zero to 10 (zero="not confident at all"; 10="totally confident"). The score for the scale is the mean of the composite scores of the 6 Likert scales.

  1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion

Secondary Outcomes (3)

• Change in score on Brief COPE Inventory from baseline to repeat visits

  1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion

• Change in score on National Comprehensive Cancer Network Distress Thermometer from baseline to repeat visits

  1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion

• Change in score on McGill Quality of Life Scale (Revised) from baseline to repeat visits

  1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion

Study Arms (2)

Massages

EXPERIMENTAL

During routine clinic visits, subjects will receive a total of six 30-minute massages (one massage per week for 4 weeks, then one massage every two weeks for 4 weeks).

Other: Massage

Control

NO INTERVENTION

Subjects randomized to the control arm will also attend routine clinic visits at the same pre-prescribed intervals (one clinic visit per for 4 weeks, then one visit every two weeks for 4 weeks).

Interventions

Massage OTHER

Massage intervention including effleurage, petrissage and energy work/Reiki at a pressure of 2 or less (Walton Pressure Scale)

Massages

Eligibility Criteria

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

You may qualify if:

• capacitated, at least 18 years of age, received LVAD implant during last hospital admission

You may not qualify if:

• incapacitated, non-English speaking, negative pressure isolation, unstable spine, very low serum platelets (\<10,000/uL), received massage in 30 days prior to enrollment

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Massage

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

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: Investigator

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: July 12, 2019
• Study Start: September 1, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)