Mindfulness training to improve heart failure self-care and cognitive function
Targeting Cognitive Function and Interoceptive Awareness to Improve Self-management in Patients With Co-morbid Heart Failure and Cognitive Impairment.
This study is testing whether mindfulness training can help people with heart failure and mild cognitive impairment take better care of themselves and improve their thinking skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Miriam Hospital Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT05431192 on ClinicalTrials.gov |
What this trial studies
This project investigates the impact of mindfulness training (MT) on self-care in patients with heart failure (HF) and mild cognitive impairment (MCI). A total of 176 stable outpatients will be randomly assigned to receive either phone-delivered MT combined with enhanced usual care or enhanced usual care alone. The MT consists of weekly 30-minute sessions for 8 weeks, along with daily guided practice. Participants will undergo comprehensive assessments of cognitive function, psycho-behavioral factors, cardiac vagal control, and HF biomarkers at baseline, 3 months, and 9 months after enrollment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a documented diagnosis of heart failure and mild cognitive impairment.
Not a fit: Patients with severe cognitive impairment or unstable heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance cognitive function and self-care in patients with heart failure and cognitive impairment.
How similar studies have performed: Other studies have shown promise in using mindfulness approaches for improving health outcomes, suggesting potential success for this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Providence, Rhode Island
- The Miriam Hospital — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: Elena Salmoirago-Blotcher, MD, PhD — Cardiovascular Institute, The Miriam Hospital, Brown University
- Study coordinator: Elena Salmoirago-Blotcher, MD, PhD
- Email: Elena_Salmoirago-Blotcher@brown.edu
- Phone: 401-793-8325
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.