R01AG076438

Targeting Cognitive Function and Interoceptive Awareness to Improve Self-Management in Patients with Co-Morbid Heart Failure and Cognitive Impairment

Project Summary/Abstract

Due to population aging, heart failure (HF) is reaching pandemic proportions and is now the most common hospital discharge diagnosis among older adults in the United States. HF carries an unfavorable prognosis, with both 6-month hospital readmissions and 5-year mortality rates reaching 50%. To improve clinical outcomes, it is critical that patients implement adequate self-care, i.e., they adhere to pharmacological and lifestyle recommendations and monitor their symptoms to ensure they receive medical attention in a timely fashion.

Mild cognitive impairment (MCI) affects up to two-thirds of patients with HF and is a key barrier to their ability to effectively implement self-care. Despite its negative impact on self-care and on clinical outcomes, only a small number of self-care intervention studies specifically address MCI, and interventions targeting this important comorbidity are sorely needed.

There is preliminary evidence that mindfulness training (MT) can improve cognitive function in individuals with MCI. MT has also been shown to improve interoceptive awareness, a skill which could increase the patient's ability to recognize worsening of HF symptoms in a timely fashion, receive treatment sooner, and potentially prevent re-admissions. Finally, by eliciting the relaxation response, MT enhances vagal control, which has been associated with better cognitive function.

This application, designed in response to PAR-20-180 "Identifying Innovative Mechanisms or Interventions that Target Multimorbidity and Its Consequences" and in line with NIA interests, will leverage our expertise with remote MT for patients with chronic conditions to conduct a phase II mechanistic RCT with the following objectives:

A) To study the effects of MT on cognitive function and interoceptive awareness in patients with co-morbid MCI and HF,
B) To assess whether improvements in these proximal factors could positively impact self-care, and
C) To study the underlying physiological mechanisms by which MT could improve cognition in this population.

Stable outpatients (N=176) with HF and MCI will be randomly assigned to phone-delivered MT (a weekly, 30-minute session for 8 weeks integrated with a 20-minute guided daily individual practice via digital recordings) plus enhanced usual care (EUC) or to EUC alone. Consistent with 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, interoceptive awareness, HF self-care and other psycho-behavioral factors, cardiac vagal control, and HF biomarkers.

This is the first rigorous investigation of the effects of MT on cognitive function, interoceptive awareness, and self-care in patients with co-morbid MCI and HF. Demonstrating that, by improving cognitive performance and interoceptive awareness, MT promotes self-care in patients with co-morbid HF and MCI will pave the way to the integration of MT into rehabilitation programs and self-care interventions to improve clinical outcomes in this vulnerable population.

The Miriam Hospital

NOT APPLICABLE

93.866 - Aging Research

National Institute on Aging (NIA) [HHS - NIH]

Providence, Rhode Island 029034141 United States

Single Zip Code

Identifying Innovative Mechanisms or Interventions that Target Multimorbidity and Its Consequences (R01 Clinical Trial Optional) (PAR-20-180)

Amendment Since initial award the total obligations have increased 347% from $754,306 to $3,375,340.