Mind Your Heart-II (NCT05431192) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Mind Your Heart-II
United States176 participantsStarted 2022-11-30
Plain-language summary
This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 18 years old
* 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:
* Unwillingness/inability to provide informed consent
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying both heart failure and cognitive impairment together — do I have any signs of cognitive changes that my care team has noticed, and would that make this kind of study worth discussing for someone in my situation?
2The trial is measuring something called the NIH Toolbox Fluid Cognition score, which tracks things like memory, attention, and processing speed — can you explain whether those are areas of concern for me given my heart failure diagnosis?
3Since this trial is listed as 'active not recruiting,' it's no longer enrolling new participants — are there any similar studies looking at cognitive function in heart failure patients that might still be open to me?
4This study doesn't have a traditional phase like Phase I or II, which often means it's more of a behavioral or observational study rather than testing a new drug — can you help me understand what kind of intervention or approach is being tested here and whether anything like it might be available outside a trial?
5Given that heart failure can affect blood flow to the brain, is monitoring and trying to protect my cognitive health something we should be actively discussing as part of my overall care plan, trial or not?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in average Fluid Cognition Composite score from the NIH Toolbox Fluid Cognition Battery.