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

Heart Failure Clinical Trial

— TCU  

Official title:

Taking Care of Us: A Dyadic Intervention for Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04737759
• Other study ID #: 21.074
• Secondary ID: R21AG068715
• Status: Completed
• Phase: N/A
• Start date: July 9, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2024
• Source: Boston College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Taking Care of Us
A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.

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

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	Boston College	Chestnut Hill	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston College	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction Scores in Couples in the TCU Condition as a Measure of Acceptability.	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.	5 months after baseline
Primary	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
Primary	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	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.	5 months after baseline
Secondary	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.	5 months after baseline
Secondary	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.	5 months after baseline
Secondary	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.	5 months after baseline
Secondary	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.	5 months after baseline
Secondary	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.	5 months baseline
Secondary	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.	5 months after baseline
Secondary	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.	5 months after baseline
Secondary	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.	5 months after baseline
Secondary	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.	5 months after baseline