Skip to main content
OpenTrials
Completed

NCT Number: NCT04737759

Taking Care of Us: A Dyadic Intervention for Heart Failure Couples

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center, Boston, Massachusetts, United States

Loading trial locations.

About this study

There is a critical need for theoretically- and empirically-driven dyadic interventions to improve the outcomes of both adults with heart failure and their partners. The proposed study will evaluate a novel, dyadic program, Taking Care of Us, versus an educational counseling condition using a randomized controlled trial on 72 couples living with heart failure. Both programs are offered via Zoom by trained interventionists and last approximately two months.

Specifically, we will 1) determine the efficacy of the Taking Care of Us intervention on dyadic health; 2) determine the efficacy of the Taking Care of Us intervention on dyadic appraisal and dyadic management; and 3) determine the feasibility and acceptability of the Taking Care of Us intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults with Heart Failure:

  • 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

Inclusion criteria

Spouses/Partners:

  • 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

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
  • 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

Treatment and study plan

Taking Care of Us

Behavioral

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

SUPPORT

Other

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

Primary outcomes

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

    Time frame: 5 months after baseline

    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.

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

    Time frame: 5 months after baseline

    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.

Secondary outcomes

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

    Time frame: 5 months after baseline

    Center for Epidemiological Studies Depression CESD 20-item measure. Items are on a 0-3 scale with potential range of 0-60 with higher scores indicating more depressive symptoms.

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

    Time frame: 5 months after baseline

    The 16-item Multidimensional Caregiver Strain Index measures physical, social, interpersonal strain and time constraints and demands related to providing care on a 1-5 scale. Potential range of scores is 16-80 with higher scores indicating greater strain.

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

    Time frame: 5 months after baseline

    Total quality of life score assessed by the 12-item Kansas City Cardiomyopathy Questionnaire. Items are converted to a 0-100 scale with higher scores indicating better heart failure related quality of life.

  4. Change in Difference in Dyspnea Scores in the TCU vs SUPPORT Condition

    Time frame: 5 months after baseline

    Patient dyspnea scores assessed by the 6-item Heart Failure Somatic Perception Scale. Items ask about how much the person was bothered by dyspnea during the last week on a 0 (not at all) to 5 (extremely bothersome) scale for a potential range of 0-30. Higher scores indicate greater dyspnea. It was not possible to examine changes in incongruence within couples due to small sample so between-group differences with patients and spouses (reporting their perception of patient's dyspnea) were calculated.

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

    Time frame: 5 months after baseline

    Pain interference was assessed using the six-item PROMIS pain interference scale with items ranging from 1-5 for a potential range of 6-30. Higher scores indicate more pain interference. It was not possible to examine changes in incongruence within couples due to small sample so between-group differences with patients and spouses (reporting their perception of patient's pain interference) were calculated.

  6. Change in Difference in Fatigue Scores in Couples in the TCU vs SUPPORT Condition.

    Time frame: 5 months baseline

    Fatigue was assessed using the eight-item PROMIS fatigue scale with items on a 1-5 scale for a potential range of 8-40. Higher scored indicate more fatigue. It was not possible to examine changes in incongruence within couples due to small sample so between-group differences with patients and spouses (reporting their perception of patient's fatigue) were calculated.

  7. Change in Collaboration Scores in Couples in the TCU vs SUPPORT Condition

    Time frame: 5 months after baseline

    Collaborative symptom management was assessed using the six-item Stanford Chronic Disease Self-Management measure with items reworded to ask how much couples worked together to prevent symptoms (e.g., fatigue, pain, emotional distress) from interfering with what the person with heart failure wanted to do or to reduce the need to see a provider on a 1 (never) to 10 (always) scale. Average summary scores had the potential to range from 1-10 with higher scores indicating greater collaborative management.

  8. Change in Confidence Scores in Couples in the TCU vs SUPPORT Condition

    Time frame: 5 months after baseline

    Confidence was measured using the 6-item Stanford Chronic Disease Self-Management measure to assess confidence to manage six aspects of the illness (e.g., fatigue, emotional distress) on a 1 (no confidence) to 10 (a great deal of confidence) scale. Summary scores were calculated by average the six items for a potential range of 1-10.Higher scores indicate greater confidence.

  9. Change in Communication Scores on the Active Engagement Subscale in Couples in the TCU vs SUPPORT Condition

    Time frame: 5 months after baseline

    Communication within the couple was assessed using both scales from the Dyadic Coping measure. Active engagement has five items that ask about how much one's partner engages in open communication and support on a 1-5 scale for a possible range of 5-25. Higher scores indicate one's partner has a higher level of active engagement.

  10. Change in Communication Scores on the Protective Buffering Subscale in Couples in the TCU vs SUPPORT Condition

    Time frame: 5 months after baseline

    Communication within the couple was assessed using both scales from the Dyadic Coping measure. Protective buffering has six items that ask about how much one's partner engages in hiding concerns and denying worries on a 1-5 scale for a possible range of 6-30. Higher scores indicate one's partner has a higher level of protective buffering.

Other outcomes

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

    Time frame: 5 months after baseline

    Satisfaction with the assigned program was assessed with a Likert item adapted from other intervention work about the benefits and drawbacks of the program. Participants were asked to rate their satisfaction with the overall program on a 1 to 4 scale with higher scores indicating greater satisfaction.

Sponsors and collaborators

Lead sponsor

Boston College

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Taking Care of Us: A Dyadic Intervention for Heart Failure

Acronym: TCU

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 4, 2021
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.