Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
176 participants
INTERVENTIONAL
2022-11-30
2026-12-31
Brief Summary
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Detailed Description
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This study has the following objectives:
1. To study the role of MT in improving cognitive function and HF self-care in patients with co-morbid HF and MCI. We hypothesize: 1a) Cognitive function will improve in MT vs. EUC at end of treatment (3 months); 1b) Improvements in cognitive function at end of treatment will mediate effects on self-care and HF biomarkers at follow-up (9 months since baseline).
2. To study the role of MT in improving interoceptive awareness and HF self-care in patients with co-morbid HF and MCI. We hypothesize: 2a) Interoceptive awareness will improve in MT vs. EUC at 3 months, and 2b) Changes in interoceptive awareness at end of treatment will mediate improvements in self-care and HF biomarkers at 9 months follow-up.
3. To study the mechanistic pathway linking MT, vagal control and cognitive function. We hypothesize: 3a) Vagal control will improve in MT vs. EUC at end of treatment (3 months); 3b) Changes in vagal control will mediate improvements in cognitive performance at 9 months of follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Unblinded personnel will include the PD, the RA, and the MT instructors. Blinding the PD would be impossible given that she will be responsible for randomization and AEs monitoring.
The RA will be responsible for data collection and will not be blinded. We note, however, that study participants will independently perform all assessments via computer interface with no RA involvement.
The mindfulness instructors will be aware of the allocation status of the participants but will remain masked to the study hypotheses.
Study Groups
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Mindful Training + Enhanced Usual Care
Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks.
Mindfulness Training + Enhanced Usual Care
Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks. MT involves training in the following (1) Awareness of breath; (2) Body scan; (3) Directing attention to simple activities of daily life; (4) Becoming aware of own thoughts and emotions; (5) "Open awareness" - a technique by which the participant is invited to direct his/her attention to any event arising in their field of experience at a given moment.
In addition, participants will practice mindfulness techniques for 20 minutes daily on their own with the guidance of a digitally recorded, standardized guided mindfulness practice.
Enhanced Usual Care alone
Usual care.
Enhanced Usual Care
Usual care will be enhanced in BOTH conditions with printed education materials provided to all participants using publicly available materials (the "Healthier Living with Heart Failure" guide available at the AHA Heart Failure Resource Center).66 The guide is organized in 7 chapters containing information on topics such as understanding HF, making healthy lifestyle changes, managing HF symptoms, taking medications, and living well with HF. Printed materials will be mailed weekly to all participants during the first 8 weeks of the study.
Interventions
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Mindfulness Training + Enhanced Usual Care
Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks. MT involves training in the following (1) Awareness of breath; (2) Body scan; (3) Directing attention to simple activities of daily life; (4) Becoming aware of own thoughts and emotions; (5) "Open awareness" - a technique by which the participant is invited to direct his/her attention to any event arising in their field of experience at a given moment.
In addition, participants will practice mindfulness techniques for 20 minutes daily on their own with the guidance of a digitally recorded, standardized guided mindfulness practice.
Enhanced Usual Care
Usual care will be enhanced in BOTH conditions with printed education materials provided to all participants using publicly available materials (the "Healthier Living with Heart Failure" guide available at the AHA Heart Failure Resource Center).66 The guide is organized in 7 chapters containing information on topics such as understanding HF, making healthy lifestyle changes, managing HF symptoms, taking medications, and living well with HF. Printed materials will be mailed weekly to all participants during the first 8 weeks of the study.
Eligibility Criteria
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Inclusion Criteria
* A documented diagnosis of HF
* Access to a telephone
* Mild cognitive impairment (MoCA score \< = 26)
* Ability to understand and speak English or Spanish
Exclusion Criteria
* Reversible causes of HF (e.g., takotsubo syndrome; myocarditis)
* Severe hearing impairment not allowing phone delivery
* Suicidal ideation or plan
* Current (at least once a month) mind/body practice
* Planning to move out of the area during the study period
* Severe cognitive impairment (MoCA scores \< 15)
* New York Heart Association (NYHA) class IV heart failure or clinically unstable
* Ongoing psychiatric or neurologic conditions
* Current enrollment in another study
18 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
The Miriam Hospital
OTHER
Responsible Party
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Elena Salmoirago-Blotcher
Senior Research Scientist
Principal Investigators
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Elena Salmoirago-Blotcher, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Institute, The Miriam Hospital, Brown University
Locations
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The Miriam Hospital
Providence, Rhode Island, United States
Countries
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Central Contacts
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Other Identifiers
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