NCT04737759

Brief Summary

This research study is evaluating the efficacy and feasibility of a novel, dyadic intervention for heart failure couples versus an educational counseling intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

July 9, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 12, 2024

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

1.9 years

First QC Date

January 27, 2021

Results QC Date

May 3, 2024

Last Update Submit

June 10, 2024

Conditions

Heart Failure

Keywords

CouplesSpousesDyads

Outcome Measures

Primary Outcomes (2)

  • Change in Physical Quality of Life Scores in Couples in the TCU vs SUPPORT Condition.

    Physical quality of life score from the 10-item PROMIS Global Health Short Form. 4 items recoded to 1-5 scale for potential range of 1-20. Higher scores indicate better physical quality of life.

    5 months after baseline

  • Change in Mental Quality of Life Scores in Couples in the TCU vs SUPPORT Condition.

    Mental quality of life score from the 10-item PROMIS Global Health Short Form. 4 items recoded to 1-5 scale for potential range of 1-20. Higher scores indicate better mental quality of life.

    5 months after baseline

Secondary Outcomes (10)

  • Change in Depressive Symptom Scores in Couples in the TCU vs SUPPORT Condition.

    5 months after baseline

  • Change in Care Strain Scores in Spouses in the TCU vs SUPPORT Condition.

    5 months after baseline

  • Change in Heart Failure Related Quality of Life Scores in Persons With Heart Failure in the TCU vs SUPPORT Condition

    5 months after baseline

  • Change in Difference in Dyspnea Scores in the TCU vs SUPPORT Condition

    5 months after baseline

  • Change in Difference in Pain Interference Scores in Couples in the TCU vs SUPPORT Condition

    5 months after baseline

  • +5 more secondary outcomes

Other Outcomes (1)

  • Satisfaction Scores in Couples in the TCU Condition as a Measure of Acceptability.

    5 months after baseline

Study Arms (2)

Taking Care of Us

EXPERIMENTAL

Taking Care of Us involves seven sessions delivered via Zoom to couples over approximately two months. Sessions last approximately 45-60 minutes and are delivered by a trained interventionist. The program is a communication-based, relationship-focused intervention that is strengths-based and fosters new skills to support couples managing heart failure. The goals of the program are to 1) target the couple with heart failure as a team; 2) increase shared appraisal within the couple; 3) improve communication skills within the couple; 4) improve collaboration within the couple and dyadic management of heart failure; 5) improve confidence within the couple; and 6) improve both individual and dyadic health and well-being.

Behavioral: Taking Care of Us

SUPPORT

ACTIVE COMPARATOR

The SUPPORT program involves three sessions delivered via Zoom to couples over approximately two months. Sessions last approximately 45-60 minutes and are delivered by a trained interventionist. This arm is an educational intervention to support management of heart failure.

Other: SUPPORT

Interventions

Taking Care of UsBEHAVIORAL

A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.

Taking Care of Us
SUPPORTOTHER

SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.

SUPPORT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of heart failure for at least three months
  • Current heart failure symptoms (i.e., NYHA Class II-III; AHA/ACC Stage C)
  • Age greater than or equal to 18 years
  • Willing and able to provide informed consent
  • Reachable by telephone/email
  • Access to device with camera (e.g., computer, tablet) to participate in Zoom sessions
  • Have a co-residing spouse/unmarried partner willing to participate
  • Age greater than or equal to 18 years
  • Co-residing with the adult with heart failure at time of recruitment
  • Have lived with the adult with heart failure for at least one year
  • Willing and able to provide informed consent

You may not qualify if:

  • Major and uncorrected hearing impairment
  • Significant cognitive impairment
  • Heart transplantation/mechanical circulatory support prior to enrollment
  • Concomitant terminal illness that would impede participation
  • Active psychosis or severe substance abuse that would impair the ability to complete the study
  • Inability to complete the requirements of the study, including enrolment in an additional trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Boston College

Chestnut Hill, Massachusetts, 02467, United States

Location

Related Publications (2)

  • Lyons KS, Whitlatch CJ, Vest AR, Upshaw JN, Hutton Johnson S, Walters A, Lee CS. Feasibility, Acceptability, and Preliminary Efficacy of the Taking Care of Us Intervention for Couples Living With Heart Failure. Innov Aging. 2024 Dec 7;9(1):igae106. doi: 10.1093/geroni/igae106. eCollection 2025.

    PMID: 39790834DERIVED

  • Lyons KS, Whitlatch CJ, Vest AR, Upshaw JN, Johnson SH, Morelock J, Lee CS. Taking Care of Us(c) (TCU) study protocol: feasibility and acceptability of a dyadic intervention for couples living with heart failure. Pilot Feasibility Stud. 2023 Jan 25;9(1):16. doi: 10.1186/s40814-023-01249-7.

    PMID: 36698174DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Karen Lyons
Organization
Boston College
karen.lyons@bc.edu
6175526379

Study Officials

  • Karen S Lyons, PhD

    Boston College

    PRINCIPAL INVESTIGATOR

  • Christopher S Lee, PhD, RN

    Boston College

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 4, 2021

Study Start

July 9, 2021

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

June 12, 2024

Results First Posted

June 12, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)