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Mind Your Heart-II (MYH-II)

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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:

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). 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. 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

Trial contacts and locations

1

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Central trial contact

Elena Salmoirago-Blotcher, MD, PhD; Janice Tripolone, MS

Data sourced from clinicaltrials.gov

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