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Taking Care of Us


Title Taking Care of Us: A dyadic intervention for heart failure
Therapeutic Area Heart Failure
Principal Investigator Amanda Vest, MD
Min Age 18 Years
Gender All
Contact Karen Lyons
617-552-1830
More Information https://clinicaltrials.gov/ct2/show/NCT04737759

Overview

The proposed dyadic intervention will be one of the first to target the outcomes of both the HF patient and their spouse care partner simultaneously through a team-based intervention centered on shared appraisal, collaboration, communication and confidence to promote optimal dyadic health. The proposed study is, therefore, significant in addressing an important gap. Our study will determine the feasibility, acceptability and clinical meaningfulness of the Taking Care of Us program, providing vital information needed to move closer to our long-term goal to successfully translate this program into multiple delivery modalities (for maximum reach) and inform clinical practice. Results of this study will provide vital information to move us closer to translating successful programs into clinical practice and shed important light on whether, for whom, and how the Taking Care of Us program benefits both members of the HF care dyad

Study Details

Inclusion Criteria

  • Confirmed diagnosis of HF 1 year by physical exam and echocardiographic evidence
  • Current HF symptoms (i.e. NYHA Class II-III; AHA/ACC Stage C HF)
  • Access to device with camera (e.g., computer, tablet) to participate in Zoom sessions
  • Have a co-residing spouse/unmarried partner willing to participate

Exclusion Criteria

  • Major and uncorrected hearing impairment
  • Significant cognitive impairment
  • Heart transplantation/mechanical circulatory support prior to enrollment
  • Concomitant terminal illness that would impede participation in a longitudinal study
  • Major psychiatric illness
  • Inability to complete the requirements of the study, including enrolment in an additional intervention trial

Study Requirements

The proposed study is a two-group randomized controlled trial with separate assessments of patients and care partners at 0, 14 and 28 weeks. Approximately 6 dyads will be recruited per month over 12 months for a total of 72 dyads. All participants will be assessed three times baseline, 14 and 28 weeks. The rationale for selecting 14 weeks as the first follow-up is based on 7 biweekly sessions delivered over an average of 3 months. We believe 7 biweekly sessions over 14 weeks with the first followup interview taking place immediately at 14 weeks to be realistic and appropriate for this population. Our second follow-up will take place approximately 3 months later at 28 weeks to explore sustained effects. The attention-control group will receive three educational sessions over 14 weeks (at approximately 2-, 8- and 14 weeks).

Baseline interviews will take approximately 45 minutes to complete with 14 and 28 week follow-up interviews taking approximately 30 minutes to complete.