Back to resultsMassage Therapy for Self-efficacy in LVAD Recipients
Primary Purpose
Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Massage
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring left ventricular assist device, massage, coping, self efficacy
Eligibility 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
Sites / Locations
- MedStar Washington Hospital Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Massages
Control
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in score on Brief COPE Inventory from baseline to repeat visits
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.
Change in score on National Comprehensive Cancer Network Distress Thermometer from baseline to repeat visits
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.
Change in score on McGill Quality of Life Scale (Revised) from baseline to repeat visits
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.
Full Information
NCT ID
NCT04018508
First Posted
June 13, 2019
Last Updated
June 13, 2022
Sponsor
Medstar Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04018508
Brief Title
Massage Therapy for Self-efficacy in LVAD Recipients
Official Title
Pilot Study of Massage Therapy to Improve Self-efficacy in Patients With Left-ventricular Device
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID19 pandemic closed in-person clinics; LVAD surgeon left institution, stopping LVAD implants
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medstar Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
left ventricular assist device, massage, coping, self efficacy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Massages
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Massage
Intervention Description
Massage intervention including effleurage, petrissage and energy work/Reiki at a pressure of 2 or less (Walton Pressure Scale)
Primary Outcome Measure Information:
Title
Change in Self-Efficacy for Managing Chronic Disease 6-item Scale from Baseline to Repeat Visits
Description
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.
Time Frame
1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
Secondary Outcome Measure Information:
Title
Change in score on Brief COPE Inventory from baseline to repeat visits
Description
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.
Time Frame
1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
Title
Change in score on National Comprehensive Cancer Network Distress Thermometer from baseline to repeat visits
Description
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.
Time Frame
1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
Title
Change in score on McGill Quality of Life Scale (Revised) from baseline to repeat visits
Description
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.
Time Frame
1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Massage Therapy for Self-efficacy in LVAD Recipients
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