Mind Your Heart-II (MYH-II)

Lifespan

Status: Enrolling

Conditions: Cognitive Impairment; Heart Failure

Treatments: Behavioral: Mindfulness Training + Enhanced Usual Care; Other: Enhanced Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05431192

R01AG076438 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment.

Full description

Stable outpatients patients with co-morbid heart failure (HF) and mild cognitive impairment (MCI) (n=176) will be randomly assigned to phone-delivered MT (a weekly, 30-minute session for 8 weeks integrated with 20-min daily guided individual practice via digital recordings) plus enhanced usual care (EUC) or to EUC alone. Per current recommendations, usual care will be enhanced in both groups with self-care education materials. At baseline, 3 months (end of treatment), and 9 months since baseline participants will undergo comprehensive assessments of cognitive function, psycho-behavioral factors, cardiac vagal control, and HF biomarkers.

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.

Enrollment: 176 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

176 participants in 2 patient groups

Mindful Training + Enhanced Usual Care

Experimental group

Description:

Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks.

Treatment:

Behavioral: Mindfulness Training + Enhanced Usual Care

Enhanced Usual Care alone

Other group

Description:

Usual care.

Treatment:

Other: Enhanced Usual Care