Trial Outcomes & Findings for Taking Care of Us: A Dyadic Intervention for Heart Failure Couples (NCT NCT04737759)
NCT ID: NCT04737759
Last Updated: 2024-06-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
74 participants
Primary outcome timeframe
5 months after baseline
Results posted on
2024-06-12
Participant Flow
74 participants (37 couples). Recruitment began February 2021. Participants completed consent and enrolled between July 2021 and November 2022. Study investigators at Tufts Medical Center Heart Failure clinic, Boston, MA provided patients with recruitment materials in-person (when possible) and via mailings. Recruitment also involved community outreach locally (e.g., councils on aging, newsletters, media), nationally via social media, websites and clinical colleagues.
Participant milestones
| Measure |
Taking Care of Us
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.
Taking Care of Us: A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
|
SUPPORT
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.
SUPPORT: SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
38
|
|
Overall Study
Adults With Heart Failure
|
18
|
19
|
|
Overall Study
Spouse/Partners
|
18
|
19
|
|
Overall Study
COMPLETED
|
16
|
22
|
|
Overall Study
NOT COMPLETED
|
20
|
16
|
Reasons for withdrawal
| Measure |
Taking Care of Us
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.
Taking Care of Us: A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
|
SUPPORT
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.
SUPPORT: SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
|
|---|---|---|
|
Overall Study
Patient and spouse withdrew as adult with heart failure too sick/health decline
|
12
|
4
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
spouse dropped when adult with heart failure died
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
12
|
Baseline Characteristics
We had 37 couples participate (37 adults with heart failure and 37 spouse/partners)
Baseline characteristics by cohort
| Measure |
Taking Care of Us
n=36 Participants
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.
Taking Care of Us: A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
|
SUPPORT
n=38 Participants
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.
SUPPORT: SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Patient with heart failure age
|
64.61 Years
STANDARD_DEVIATION 15.15 • n=18 Participants • We had 37 couples participate (37 adults with heart failure and 37 spouse/partners)
|
68.03 Years
STANDARD_DEVIATION 12.33 • n=19 Participants • We had 37 couples participate (37 adults with heart failure and 37 spouse/partners)
|
66.32 Years
STANDARD_DEVIATION 13.72 • n=37 Participants • We had 37 couples participate (37 adults with heart failure and 37 spouse/partners)
|
|
Age, Continuous
Spouse/partner age
|
61.67 Years
STANDARD_DEVIATION 15.03 • n=18 Participants • We had 37 couples participate (37 adults with heart failure and 37 spouse/partners)
|
64.26 Years
STANDARD_DEVIATION 10.35 • n=19 Participants • We had 37 couples participate (37 adults with heart failure and 37 spouse/partners)
|
63.00 Years
STANDARD_DEVIATION 12.73 • n=37 Participants • We had 37 couples participate (37 adults with heart failure and 37 spouse/partners)
|
|
Sex: Female, Male
Patient with heart failure · Female
|
4 Participants
n=18 Participants • 37 couples for total of 74 participants (37 patients and 37 partners)
|
4 Participants
n=19 Participants • 37 couples for total of 74 participants (37 patients and 37 partners)
|
8 Participants
n=37 Participants • 37 couples for total of 74 participants (37 patients and 37 partners)
|
|
Sex: Female, Male
Patient with heart failure · Male
|
14 Participants
n=18 Participants • 37 couples for total of 74 participants (37 patients and 37 partners)
|
15 Participants
n=19 Participants • 37 couples for total of 74 participants (37 patients and 37 partners)
|
29 Participants
n=37 Participants • 37 couples for total of 74 participants (37 patients and 37 partners)
|
|
Sex: Female, Male
Spouse/Partner · Female
|
14 Participants
n=18 Participants • 37 couples for total of 74 participants (37 patients and 37 partners)
|
15 Participants
n=19 Participants • 37 couples for total of 74 participants (37 patients and 37 partners)
|
29 Participants
n=37 Participants • 37 couples for total of 74 participants (37 patients and 37 partners)
|
|
Sex: Female, Male
Spouse/Partner · Male
|
4 Participants
n=18 Participants • 37 couples for total of 74 participants (37 patients and 37 partners)
|
4 Participants
n=19 Participants • 37 couples for total of 74 participants (37 patients and 37 partners)
|
8 Participants
n=37 Participants • 37 couples for total of 74 participants (37 patients and 37 partners)
|
|
Ethnicity (NIH/OMB)
Patient with heart failure · Hispanic or Latino
|
0 Participants
n=18 Participants • 37 couples
|
1 Participants
n=19 Participants • 37 couples
|
1 Participants
n=37 Participants • 37 couples
|
|
Ethnicity (NIH/OMB)
Patient with heart failure · Not Hispanic or Latino
|
18 Participants
n=18 Participants • 37 couples
|
18 Participants
n=19 Participants • 37 couples
|
36 Participants
n=37 Participants • 37 couples
|
|
Ethnicity (NIH/OMB)
Patient with heart failure · Unknown or Not Reported
|
0 Participants
n=18 Participants • 37 couples
|
0 Participants
n=19 Participants • 37 couples
|
0 Participants
n=37 Participants • 37 couples
|
|
Ethnicity (NIH/OMB)
Spouse/Partner · Hispanic or Latino
|
1 Participants
n=18 Participants • 37 couples
|
0 Participants
n=19 Participants • 37 couples
|
1 Participants
n=37 Participants • 37 couples
|
|
Ethnicity (NIH/OMB)
Spouse/Partner · Not Hispanic or Latino
|
17 Participants
n=18 Participants • 37 couples
|
19 Participants
n=19 Participants • 37 couples
|
36 Participants
n=37 Participants • 37 couples
|
|
Ethnicity (NIH/OMB)
Spouse/Partner · Unknown or Not Reported
|
0 Participants
n=18 Participants • 37 couples
|
0 Participants
n=19 Participants • 37 couples
|
0 Participants
n=37 Participants • 37 couples
|
|
Race (NIH/OMB)
Patient with heart failure · American Indian or Alaska Native
|
0 Participants
n=18 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=19 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=37 Participants • 37 couples (37 patients and 37 partners)
|
|
Race (NIH/OMB)
Patient with heart failure · Asian
|
0 Participants
n=18 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=19 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=37 Participants • 37 couples (37 patients and 37 partners)
|
|
Race (NIH/OMB)
Patient with heart failure · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=19 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=37 Participants • 37 couples (37 patients and 37 partners)
|
|
Race (NIH/OMB)
Patient with heart failure · Black or African American
|
0 Participants
n=18 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=19 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=37 Participants • 37 couples (37 patients and 37 partners)
|
|
Race (NIH/OMB)
Patient with heart failure · White
|
17 Participants
n=18 Participants • 37 couples (37 patients and 37 partners)
|
18 Participants
n=19 Participants • 37 couples (37 patients and 37 partners)
|
35 Participants
n=37 Participants • 37 couples (37 patients and 37 partners)
|
|
Race (NIH/OMB)
Patient with heart failure · More than one race
|
1 Participants
n=18 Participants • 37 couples (37 patients and 37 partners)
|
1 Participants
n=19 Participants • 37 couples (37 patients and 37 partners)
|
2 Participants
n=37 Participants • 37 couples (37 patients and 37 partners)
|
|
Race (NIH/OMB)
Patient with heart failure · Unknown or Not Reported
|
0 Participants
n=18 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=19 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=37 Participants • 37 couples (37 patients and 37 partners)
|
|
Race (NIH/OMB)
Spouse/partner · American Indian or Alaska Native
|
0 Participants
n=18 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=19 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=37 Participants • 37 couples (37 patients and 37 partners)
|
|
Race (NIH/OMB)
Spouse/partner · Asian
|
0 Participants
n=18 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=19 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=37 Participants • 37 couples (37 patients and 37 partners)
|
|
Race (NIH/OMB)
Spouse/partner · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=19 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=37 Participants • 37 couples (37 patients and 37 partners)
|
|
Race (NIH/OMB)
Spouse/partner · Black or African American
|
0 Participants
n=18 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=19 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=37 Participants • 37 couples (37 patients and 37 partners)
|
|
Race (NIH/OMB)
Spouse/partner · White
|
18 Participants
n=18 Participants • 37 couples (37 patients and 37 partners)
|
19 Participants
n=19 Participants • 37 couples (37 patients and 37 partners)
|
37 Participants
n=37 Participants • 37 couples (37 patients and 37 partners)
|
|
Race (NIH/OMB)
Spouse/partner · More than one race
|
0 Participants
n=18 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=19 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=37 Participants • 37 couples (37 patients and 37 partners)
|
|
Race (NIH/OMB)
Spouse/partner · Unknown or Not Reported
|
0 Participants
n=18 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=19 Participants • 37 couples (37 patients and 37 partners)
|
0 Participants
n=37 Participants • 37 couples (37 patients and 37 partners)
|
|
Region of Enrollment
United States
|
36 Participants
n=36 Participants
|
38 Participants
n=38 Participants
|
74 Participants
n=74 Participants
|
|
Education Level
Patients with heart failure
|
11 Participants
n=18 Participants • 37 couples (37 patients and 37 partners)
|
16 Participants
n=19 Participants • 37 couples (37 patients and 37 partners)
|
27 Participants
n=37 Participants • 37 couples (37 patients and 37 partners)
|
|
Education Level
Spouse/Partners
|
14 Participants
n=18 Participants • 37 couples (37 patients and 37 partners)
|
16 Participants
n=19 Participants • 37 couples (37 patients and 37 partners)
|
30 Participants
n=37 Participants • 37 couples (37 patients and 37 partners)
|
|
Heart failure severity
|
2.28 units on a scale
STANDARD_DEVIATION 0.9 • n=18 Participants • Only patients self-reported on heart failure severity.
|
2.21 units on a scale
STANDARD_DEVIATION 0.86 • n=19 Participants • Only patients self-reported on heart failure severity.
|
2.24 units on a scale
STANDARD_DEVIATION 0.86 • n=37 Participants • Only patients self-reported on heart failure severity.
|
|
Financial insecurity
|
4 Participants
n=18 Participants • Self-reported by patients
|
3 Participants
n=19 Participants • Self-reported by patients
|
7 Participants
n=37 Participants • Self-reported by patients
|
PRIMARY outcome
Timeframe: 5 months after baselinePopulation: Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used.
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.
Outcome measures
| Measure |
Taking Care of Us
n=36 Participants
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.
Taking Care of Us: A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
|
SUPPORT
n=38 Participants
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.
SUPPORT: SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
|
|---|---|---|
|
Change in Physical Quality of Life Scores in Couples in the TCU vs SUPPORT Condition.
Patients with heart failure
|
1.28 units on a scale
Standard Deviation 1.74
|
-0.03 units on a scale
Standard Deviation 1.51
|
|
Change in Physical Quality of Life Scores in Couples in the TCU vs SUPPORT Condition.
Spouse/partner
|
0.59 units on a scale
Standard Deviation 1.42
|
-0.63 units on a scale
Standard Deviation 1.92
|
PRIMARY outcome
Timeframe: 5 months after baselinePopulation: Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used.
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.
Outcome measures
| Measure |
Taking Care of Us
n=36 Participants
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.
Taking Care of Us: A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
|
SUPPORT
n=38 Participants
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.
SUPPORT: SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
|
|---|---|---|
|
Change in Mental Quality of Life Scores in Couples in the TCU vs SUPPORT Condition.
Patients with heart failure
|
0.39 units on a scale
Standard Error 1.58
|
0.34 units on a scale
Standard Error 1.83
|
|
Change in Mental Quality of Life Scores in Couples in the TCU vs SUPPORT Condition.
Spouse/partner
|
0.50 units on a scale
Standard Error 1.58
|
-0.21 units on a scale
Standard Error 1.84
|
SECONDARY outcome
Timeframe: 5 months after baselinePopulation: Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used.
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.
Outcome measures
| Measure |
Taking Care of Us
n=36 Participants
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.
Taking Care of Us: A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
|
SUPPORT
n=38 Participants
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.
SUPPORT: SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
|
|---|---|---|
|
Change in Depressive Symptom Scores in Couples in the TCU vs SUPPORT Condition.
Patients with heart failure
|
-5.83 units on a scale
Standard Deviation 11.17
|
-0.74 units on a scale
Standard Deviation 2.71
|
|
Change in Depressive Symptom Scores in Couples in the TCU vs SUPPORT Condition.
Spouse/partner
|
-0.44 units on a scale
Standard Deviation 3.78
|
-0.40 units on a scale
Standard Deviation 3.64
|
SECONDARY outcome
Timeframe: 5 months after baselinePopulation: Intent to treat: All spouse/partners (18 in Taking Care of Us and 19 in SUPPORT) who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used.
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.
Outcome measures
| Measure |
Taking Care of Us
n=18 Participants
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.
Taking Care of Us: A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
|
SUPPORT
n=19 Participants
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.
SUPPORT: SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
|
|---|---|---|
|
Change in Care Strain Scores in Spouses in the TCU vs SUPPORT Condition.
|
-1.72 units on a scale
Standard Deviation 5.98
|
1.32 units on a scale
Standard Deviation 5.57
|
SECONDARY outcome
Timeframe: 5 months after baselinePopulation: Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used. Measure only completed by the 37 patients with heart failure.
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.
Outcome measures
| Measure |
Taking Care of Us
n=18 Participants
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.
Taking Care of Us: A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
|
SUPPORT
n=19 Participants
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.
SUPPORT: SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
|
|---|---|---|
|
Change in Heart Failure Related Quality of Life Scores in Persons With Heart Failure in the TCU vs SUPPORT Condition
|
5.90 units on a scale
Standard Deviation 13.23
|
-0.82 units on a scale
Standard Deviation 15.72
|
SECONDARY outcome
Timeframe: 5 months after baselinePopulation: Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used. Only patients with heart failure self-reported dyspnea; partners reported their perception of the patient's dyspnea.
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.
Outcome measures
| Measure |
Taking Care of Us
n=36 Participants
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.
Taking Care of Us: A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
|
SUPPORT
n=38 Participants
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.
SUPPORT: SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
|
|---|---|---|
|
Change in Difference in Dyspnea Scores in the TCU vs SUPPORT Condition
Patients with heart failure
|
-2.06 units on a scale
Standard Deviation 5.39
|
0.11 units on a scale
Standard Deviation 4.56
|
|
Change in Difference in Dyspnea Scores in the TCU vs SUPPORT Condition
Report of spouse/partner
|
-1.83 units on a scale
Standard Deviation 3.81
|
0.47 units on a scale
Standard Deviation 5.78
|
SECONDARY outcome
Timeframe: 5 months after baselinePopulation: Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used. Only patients with heart failure self-reported pain interference; partners reported their perception of the patient's pain interference.
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.
Outcome measures
| Measure |
Taking Care of Us
n=36 Participants
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.
Taking Care of Us: A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
|
SUPPORT
n=38 Participants
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.
SUPPORT: SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
|
|---|---|---|
|
Change in Difference in Pain Interference Scores in Couples in the TCU vs SUPPORT Condition
Patients with heart failure
|
-3.50 units on a scale
Standard Deviation 4.32
|
1.68 units on a scale
Standard Deviation 4.28
|
|
Change in Difference in Pain Interference Scores in Couples in the TCU vs SUPPORT Condition
Report of spouse/partner
|
-1.61 units on a scale
Standard Deviation 5.45
|
2.47 units on a scale
Standard Deviation 8.61
|
SECONDARY outcome
Timeframe: 5 months baselinePopulation: 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. Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used.
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.
Outcome measures
| Measure |
Taking Care of Us
n=36 Participants
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.
Taking Care of Us: A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
|
SUPPORT
n=38 Participants
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.
SUPPORT: SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
|
|---|---|---|
|
Change in Difference in Fatigue Scores in Couples in the TCU vs SUPPORT Condition.
Patients with heart failure
|
-2.33 units on a scale
Standard Deviation 5.65
|
-0.21 units on a scale
Standard Deviation 6.76
|
|
Change in Difference in Fatigue Scores in Couples in the TCU vs SUPPORT Condition.
Report of spouse/partner
|
-3.06 units on a scale
Standard Deviation 5.52
|
-0.42 units on a scale
Standard Deviation 6.14
|
SECONDARY outcome
Timeframe: 5 months after baselinePopulation: Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used.
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.
Outcome measures
| Measure |
Taking Care of Us
n=36 Participants
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.
Taking Care of Us: A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
|
SUPPORT
n=38 Participants
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.
SUPPORT: SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
|
|---|---|---|
|
Change in Collaboration Scores in Couples in the TCU vs SUPPORT Condition
Patients with heart failure
|
1.13 units on a scale
Standard Error 2.33
|
0.40 units on a scale
Standard Error 2.29
|
|
Change in Collaboration Scores in Couples in the TCU vs SUPPORT Condition
Spouse/partner
|
1.20 units on a scale
Standard Error 1.65
|
0.28 units on a scale
Standard Error 1.84
|
SECONDARY outcome
Timeframe: 5 months after baselinePopulation: Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used.
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.
Outcome measures
| Measure |
Taking Care of Us
n=36 Participants
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.
Taking Care of Us: A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
|
SUPPORT
n=38 Participants
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.
SUPPORT: SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
|
|---|---|---|
|
Change in Confidence Scores in Couples in the TCU vs SUPPORT Condition
Patients with heart failure
|
0.33 units on a scale
Standard Deviation 1.48
|
-0.06 units on a scale
Standard Deviation 1.96
|
|
Change in Confidence Scores in Couples in the TCU vs SUPPORT Condition
Spouse/partner
|
0.51 units on a scale
Standard Deviation 1.52
|
-0.23 units on a scale
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: 5 months after baselinePopulation: Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used.
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.
Outcome measures
| Measure |
Taking Care of Us
n=36 Participants
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.
Taking Care of Us: A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
|
SUPPORT
n=38 Participants
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.
SUPPORT: SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
|
|---|---|---|
|
Change in Communication Scores on the Active Engagement Subscale in Couples in the TCU vs SUPPORT Condition
Patients with heart failure
|
1.11 units on a scale
Standard Deviation 2.72
|
-0.58 units on a scale
Standard Deviation 3.20
|
|
Change in Communication Scores on the Active Engagement Subscale in Couples in the TCU vs SUPPORT Condition
Spouse/partner
|
2.17 units on a scale
Standard Deviation 3.79
|
0.74 units on a scale
Standard Deviation 1.91
|
SECONDARY outcome
Timeframe: 5 months after baselinePopulation: Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used.
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.
Outcome measures
| Measure |
Taking Care of Us
n=36 Participants
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.
Taking Care of Us: A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
|
SUPPORT
n=38 Participants
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.
SUPPORT: SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
|
|---|---|---|
|
Change in Communication Scores on the Protective Buffering Subscale in Couples in the TCU vs SUPPORT Condition
Patients with heart failure
|
-1.39 units on a scale
Standard Deviation 2.93
|
0.05 units on a scale
Standard Deviation 2.12
|
|
Change in Communication Scores on the Protective Buffering Subscale in Couples in the TCU vs SUPPORT Condition
Spouse/partner
|
0.00 units on a scale
Standard Deviation 4.55
|
0.42 units on a scale
Standard Deviation 2.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 months after baselinePopulation: Data from all those in the Taking Care of Us arm, who complete the 5 month follow-up.
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.
Outcome measures
| Measure |
Taking Care of Us
n=16 Participants
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.
Taking Care of Us: A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
|
SUPPORT
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.
SUPPORT: SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
|
|---|---|---|
|
Satisfaction Scores in Couples in the TCU Condition as a Measure of Acceptability.
Patients with heart failure
|
3.63 units on a scale
Standard Deviation 1.01
|
—
|
|
Satisfaction Scores in Couples in the TCU Condition as a Measure of Acceptability.
Spouse/partners
|
3.57 units on a scale
Standard Deviation 0.79
|
—
|
Adverse Events
Taking Care of Us
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
SUPPORT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place