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Massage Therapy for Self-efficacy in LVAD Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04018508
Recruitment Status : Suspended (COVID19 pandemic closed in-person clinics temporarily)
First Posted : July 12, 2019
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Hunter Groninger, Medstar Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Massage Not Applicable

Detailed Description:
Patients with advanced heart failure who undergo left-ventricular assist device (LVAD) implantation may experience notable physical and/or emotional distress associated with this lifestyle-changing procedure. Furthermore, these patients are faced with the task of coping with the trauma of surgery, creating new self-care routines, and learning to live with a lifesaving mechanical device that must always be connected to a power source.The immediate weeks and months after LVAD implantation are a critical period to lower physical and emotional distress and to influence patient coping and adaptation. In small studies, massage therapy has been increasingly used to improve patient self-efficacy and coping. In this pilot study, we investigate whether regularly scheduled massages delivered in the clinic setting improve self-efficacy and coping in this select patient population.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Study of Massage Therapy to Improve Self-efficacy in Patients With Left-ventricular Device
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : November 28, 2020
Estimated Study Completion Date : January 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Massages
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
Massage intervention including effleurage, petrissage and energy work/Reiki at a pressure of 2 or less (Walton Pressure Scale)

No Intervention: Control
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).



Primary Outcome Measures :
  1. Change in Self-Efficacy for Managing Chronic Disease 6-item Scale from Baseline to Repeat Visits [ Time Frame: 1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion ]
    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.


Secondary Outcome Measures :
  1. Change in score on Brief COPE Inventory from baseline to repeat visits [ Time Frame: 1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion ]
    The Brief COPE is a 28-item multidimensional measure of strategies used for coping or regulating cognitions in response to stressors. This abbreviated inventory (based on the complete 60-item COPE Inventory) is comprised of items that assess the frequency with which a person uses different coping strategies (e.g., "I've been turning to work or other activities to take my mind off things," "I've been making fun of the situation," "I've been criticizing myself") rated on a scale from 1, I haven't been doing this at all, to 4, I've been doing this a lot. There are 14 two-item subscales within the Brief COPE, and each is analyzed separately: (1) self-distraction, (2) active coping, (3) denial, (4) substance use, (5) use of emotional support, (6) use of instrumental support, (7) behavioral disengagement, (8) venting, (9) positive reframing, (10) planning, (11) humor, (12) acceptance, (13) religion, and (14) self-blame.

  2. Change in score on National Comprehensive Cancer Network Distress Thermometer from baseline to repeat visits [ Time Frame: 1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion ]
    The NCCN Distress Thermometer asks the patient to report his/her distress on a scale between 0 (no distress) and 10 (extreme distress). The number provided on the scale is the patient's score.

  3. Change in score on McGill Quality of Life Scale (Revised) from baseline to repeat visits [ Time Frame: 1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion ]
    The McGill Quality of Life Questionnaire (Revised) is a 15-item multidimensional tool designed to measure physical well-being, physical symptoms, psychological symptoms, existential well-being and support, as well as overall quality of life. Created for people at all stages of a life-threatening illness (from diagnosis to cure or death), the MQOL(Revised) was designed to assess general domains applicable to all clients/patients, incorporate the existential domain, balance physical and nonphysical aspects of quality of life, and include both positive and negative influences on quality of life.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018508


Locations
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United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Health Research Institute
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Responsible Party: Hunter Groninger, Investigator, Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT04018508    
Other Study ID Numbers: STUDY00000591
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hunter Groninger, Medstar Health Research Institute:
left ventricular assist device
massage
coping
self efficacy
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases