Heart FailureNCT04018508
Massage Therapy for Self-efficacy in LVAD Recipients
A study testing Massage in people with Heart Failure, run by Medstar Health Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- capacitated, at least 18 years of age, received LVAD implant during last hospital admission
Who cannot join
- incapacitated, non-English speaking, negative pressure isolation, unstable spine, very low serum platelets (<10,000/uL), received massage in 30 days prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Pilot Study of Massage Therapy to Improve Self-efficacy in Patients With Left-ventricular Device
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Massage
- Keywords
- left ventricular assist device, massage, coping, self efficacy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
Massage intervention including effleurage, petrissage and energy work/Reiki at a pressure of 2 or less (Walton Pressure Scale)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Sep 2021
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Why it stopped: COVID19 pandemic closed in-person clinics; LVAD surgeon left institution, stopping LVAD implants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hunter Groninger, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018508
- Sponsor's protocol ID
- STUDY00000591
- Status last verified
- Jun 2022
- First submitted
- 13 Jun 2019
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Massage Therapy to Improve Self-efficacy in Patients With Left-ventricular Device
- ClinicalTrials.gov ID
- NCT04018508
- Acronym / sponsor ID
- STUDY00000591
- Conditions
- Heart Failure
- Keywords
- left ventricular assist device, massage, coping, self efficacy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID19 pandemic closed in-person clinics; LVAD surgeon left institution, stopping LVAD implants
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massages | Experimental | Other: MassageDuring 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). |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- capacitated, at least 18 years of age, received LVAD implant during last hospital admission
Key exclusion criteria (1 listed)
- incapacitated, non-English speaking, negative pressure isolation, unstable spine, very low serum platelets (<10,000/uL), received massage in 30 days prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MassageMassage intervention including effleurage, petrissage and energy work/Reiki at a pressure of 2 or less (Walton Pressure Scale) | Other | Massages |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
The study was stopped early (reason given: COVID19 pandemic closed in-person clinics; LVAD surgeon left institution, stopping LVAD implants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage in people with Heart Failure, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID19 pandemic closed in-person clinics; LVAD surgeon left institution, stopping LVAD implants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.