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

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.

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

Data generated under the project will be shared as per the NIH Grant Policy and The Miriam Hospital IRB guidelines. Deidentified research data will be made available in a timely manner once the main findings from the final research data set have been accepted for publication. Access to these data will be available for educational or research purposes. Data will be deidentified to avoid linkages to individual research participants and will not contain variables that could lead to the disclosure of the identity of individual subjects. All requestors will be asked to sign a data sharing agreement that includes conditions to 1) protect the identity of participants, 2) limit use of data for educational and research purposes, 3) prevent transfer of data to other users, and 4) acknowledge the data source. The de-identified data will be shared using Excel or SPSS file formats.

Once the main findings from the final research data set have been accepted for publication.

Researchers interested in obtaining the de-identified data and associated documentation (e.g. analytical code) can make a request to the principal investigator by email.

Participants will not be masked to intervention allocation. The PI, the co-investigators, and personnel responsible for data management and analysis will be blinded to participants' exposure status.

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.