AzTrials
AzTrials

Heart FailureTCUNCT04737759

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

A study testing Taking Care of Us and SUPPORT in people with Heart Failure, run by Boston College at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Taking Care of Us and SUPPORT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
2 sitesUnited States
Study dates
9 Jul 2021to 31 May 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Boston College

    Chestnut Hill, Massachusetts, 02467

Other trials in United States

About this study

Official title: Taking Care of Us: A Dyadic Intervention for Heart Failure

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

Read the detailed description

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.

Conditions
Heart Failure
Being tested
Taking Care of Us, SUPPORT
Keywords
Couples, Spouses, Dyads
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Taking Care of UsBehavioural

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

  • SUPPORTOther

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

Study groups in NCT04737759
Study groupRoleWhat they receive
Taking Care of UsExperimentalTaking 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.
Receives: Behavioral: Taking Care of Us
SUPPORTActive comparatorThe 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.
Receives: Other: SUPPORT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 months after baseline

  2. 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.

    Measured: 5 months after baseline

Secondary outcomes (10)
  1. Change in Depressive Symptom Scores in Couples in the TCU vs SUPPORT Condition.

    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.

    Measured: 5 months after baseline

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

    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.

    Measured: 5 months after baseline

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

    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.

    Measured: 5 months after baseline

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

    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.

    Measured: 5 months after baseline

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

    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.

    Measured: 5 months after baseline

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

    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.

    Measured: 5 months baseline

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

    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.

    Measured: 5 months after baseline

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

    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.

    Measured: 5 months after baseline

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

    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.

    Measured: 5 months after baseline

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

    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.

    Measured: 5 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2021
  2. Study start9 Jul 2021
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04737759
Sponsor's protocol ID
21.074
Other IDs
R21AG068715
Acronym
TCU
Status last verified
Jun 2024
First submitted
27 Jan 2021
Last updated
12 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39790834
  • 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.

    PubMed 36698174

Questions about this trial

What is this clinical trial studying?

A study testing Taking Care of Us and SUPPORT in people with Heart Failure, run by Boston College at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Physical Quality of Life Scores in Couples in the TCU vs SUPPORT Condition. (time frame: 5 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04737759, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in