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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: SUPPORT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
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
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
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
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
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
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
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
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.
- First posted4 Feb 2021
- Study start9 Jul 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Karen Lyons, Boston College
- Investigators
- Karen S Lyons, PhD, Principal investigator, Boston CollegeChristopher S Lee, PhD, RN, Principal investigator, Boston College
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 39790834Lyons 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taking Care of Us: A Dyadic Intervention for Heart Failure
- ClinicalTrials.gov ID
- NCT04737759
- Acronym / sponsor ID
- TCU / 21.074
- Conditions
- Heart Failure
- Keywords
- Couples, Spouses, Dyads
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Posted 12 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is evaluating the efficacy and feasibility of a novel, dyadic intervention for heart failure couples versus an educational counseling intervention.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taking Care of Us | Experimental | Behavioral: Taking Care of UsTaking 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. |
| SUPPORT | Active comparator | Other: SUPPORTThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taking Care of UsA social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom. | Behavioural | Taking Care of Us |
| SUPPORTSUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom. | Other | SUPPORT |
Primary outcome
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.
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.
10 secondary outcomes
Change in Depressive Symptom Scores in Couples in the TCU vs SUPPORT Condition.
Time frame: 5 months after baseline
Change in Care Strain Scores in Spouses in the TCU vs SUPPORT Condition.
Time frame: 5 months after baseline
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
Change in Difference in Dyspnea Scores in the TCU vs SUPPORT Condition
Time frame: 5 months after baseline
Change in Difference in Pain Interference Scores in Couples in the TCU vs SUPPORT Condition
Time frame: 5 months after baseline
Change in Difference in Fatigue Scores in Couples in the TCU vs SUPPORT Condition.
Time frame: 5 months baseline
Change in Collaboration Scores in Couples in the TCU vs SUPPORT Condition
Time frame: 5 months after baseline
Change in Confidence Scores in Couples in the TCU vs SUPPORT Condition
Time frame: 5 months after baseline
Change in Communication Scores on the Active Engagement Subscale in Couples in the TCU vs SUPPORT Condition
Time frame: 5 months after baseline
Change in Communication Scores on the Protective Buffering Subscale in Couples in the TCU vs SUPPORT Condition
Time frame: 5 months after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39790834Lyons 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.
- Derived from this study: PubMed 36698174Lyons 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen S Lyons, PhD principal investigator
Boston College
Christopher S Lee, PhD, RN principal investigator
Boston College
2 sites in 1 country: see every site and its status.
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.