Heart Failure
Conditions
Keywords
Couples, Spouses, Dyads
Brief summary
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.
Interventions
BEHAVIORALTaking Care of Us
A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
OTHERSUPPORT
SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
Sponsors
National Institute on Aging (NIA)
Boston College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mental Quality of Life Scores in Couples in the TCU vs SUPPORT Condition. | 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. |
| Change in Physical Quality of Life Scores in Couples in the TCU vs SUPPORT Condition. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Care Strain Scores in Spouses in the TCU vs SUPPORT Condition. | 5 months after baseline | The 16-item Multidimensional Caregiver Strain Index measures physical, social, interpersonal strain and time constraints and demands related to providing care on a 1-5 scale. Potential range of scores is 16-80 with higher scores indicating greater strain. |
| Change in Heart Failure Related Quality of Life Scores in Persons With Heart Failure in the TCU vs SUPPORT Condition | 5 months after baseline | Total quality of life score assessed by the 12-item Kansas City Cardiomyopathy Questionnaire. Items are converted to a 0-100 scale with higher scores indicating better heart failure related quality of life. |
| Change in Difference in Dyspnea Scores in the TCU vs SUPPORT Condition | 5 months after baseline | Patient dyspnea scores assessed by the 6-item Heart Failure Somatic Perception Scale. Items ask about how much the person was bothered by dyspnea during the last week on a 0 (not at all) to 5 (extremely bothersome) scale for a potential range of 0-30. Higher scores indicate greater dyspnea. It was not possible to examine changes in incongruence within couples due to small sample so between-group differences with patients and spouses (reporting their perception of patient's dyspnea) were calculated. |
| Change in Difference in Pain Interference Scores in Couples in the TCU vs SUPPORT Condition | 5 months after baseline | Pain interference was assessed using the six-item PROMIS pain interference scale with items ranging from 1-5 for a potential range of 6-30. Higher scores indicate more pain interference. It was not possible to examine changes in incongruence within couples due to small sample so between-group differences with patients and spouses (reporting their perception of patient's pain interference) were calculated. |
| Change in Collaboration Scores in Couples in the TCU vs SUPPORT Condition | 5 months after baseline | Collaborative symptom management was assessed using the six-item Stanford Chronic Disease Self-Management measure with items reworded to ask how much couples worked together to prevent symptoms (e.g., fatigue, pain, emotional distress) from interfering with what the person with heart failure wanted to do or to reduce the need to see a provider on a 1 (never) to 10 (always) scale. Average summary scores had the potential to range from 1-10 with higher scores indicating greater collaborative management. |
| Change in Confidence Scores in Couples in the TCU vs SUPPORT Condition | 5 months after baseline | Confidence was measured using the 6-item Stanford Chronic Disease Self-Management measure to assess confidence to manage six aspects of the illness (e.g., fatigue, emotional distress) on a 1 (no confidence) to 10 (a great deal of confidence) scale. Summary scores were calculated by average the six items for a potential range of 1-10.Higher scores indicate greater confidence. |
| Change in Communication Scores on the Active Engagement Subscale in Couples in the TCU vs SUPPORT Condition | 5 months after baseline | Communication within the couple was assessed using both scales from the Dyadic Coping measure. Active engagement has five items that ask about how much one's partner engages in open communication and support on a 1-5 scale for a possible range of 5-25. Higher scores indicate one's partner has a higher level of active engagement. |
| Change in Communication Scores on the Protective Buffering Subscale in Couples in the TCU vs SUPPORT Condition | 5 months after baseline | Communication within the couple was assessed using both scales from the Dyadic Coping measure. Protective buffering has six items that ask about how much one's partner engages in hiding concerns and denying worries on a 1-5 scale for a possible range of 6-30. Higher scores indicate one's partner has a higher level of protective buffering. |
| Change in Difference in Fatigue Scores in Couples in the TCU vs SUPPORT Condition. | 5 months baseline | Fatigue was assessed using the eight-item PROMIS fatigue scale with items on a 1-5 scale for a potential range of 8-40. Higher scored indicate more fatigue. It was not possible to examine changes in incongruence within couples due to small sample so between-group differences with patients and spouses (reporting their perception of patient's fatigue) were calculated. |
| Change in Depressive Symptom Scores in Couples in the TCU vs SUPPORT Condition. | 5 months after baseline | Center for Epidemiological Studies Depression CESD 20-item measure. Items are on a 0-3 scale with potential range of 0-60 with higher scores indicating more depressive symptoms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction Scores in Couples in the TCU Condition as a Measure of Acceptability. | 5 months after baseline | Satisfaction with the assigned program was assessed with a Likert item adapted from other intervention work about the benefits and drawbacks of the program. Participants were asked to rate their satisfaction with the overall program on a 1 to 4 scale with higher scores indicating greater satisfaction. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| 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. | 38 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 0 |
| Overall Study | Lost to Follow-up | 4 | 12 |
| Overall Study | Patient and spouse withdrew as adult with heart failure too sick/health decline | 12 | 4 |
| Overall Study | spouse dropped when adult with heart failure died | 2 | 0 |
Baseline characteristics
| Characteristic | SUPPORT | Taking Care of Us | Total |
|---|---|---|---|
| Age, Continuous Patient with heart failure age | 68.03 Years STANDARD_DEVIATION 12.33 | 64.61 Years STANDARD_DEVIATION 15.15 | 66.32 Years STANDARD_DEVIATION 13.72 |
| Age, Continuous Spouse/partner age | 64.26 Years STANDARD_DEVIATION 10.35 | 61.67 Years STANDARD_DEVIATION 15.03 | 63.00 Years STANDARD_DEVIATION 12.73 |
| Education Level Patients with heart failure | 16 Participants | 11 Participants | 27 Participants |
| Education Level Spouse/Partners | 16 Participants | 14 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Patient with heart failure Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Patient with heart failure Not Hispanic or Latino | 18 Participants | 18 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Patient with heart failure Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Spouse/Partner Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Spouse/Partner Not Hispanic or Latino | 19 Participants | 17 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Spouse/Partner Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Financial insecurity | 3 Participants | 4 Participants | 7 Participants |
| Heart failure severity | 2.21 units on a scale STANDARD_DEVIATION 0.86 | 2.28 units on a scale STANDARD_DEVIATION 0.9 | 2.24 units on a scale STANDARD_DEVIATION 0.86 |
| Race (NIH/OMB) Patient with heart failure American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patient with heart failure Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patient with heart failure Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patient with heart failure More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Patient with heart failure Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patient with heart failure Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patient with heart failure White | 18 Participants | 17 Participants | 35 Participants |
| Race (NIH/OMB) Spouse/partner American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Spouse/partner Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Spouse/partner Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Spouse/partner More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Spouse/partner Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Spouse/partner Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Spouse/partner White | 19 Participants | 18 Participants | 37 Participants |
| Region of Enrollment United States | 38 Participants | 36 Participants | 74 Participants |
| Sex: Female, Male Patient with heart failure Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Patient with heart failure Male | 15 Participants | 14 Participants | 29 Participants |
| Sex: Female, Male Spouse/Partner Female | 15 Participants | 14 Participants | 29 Participants |
| Sex: Female, Male Spouse/Partner Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 36 | 0 / 38 |
| other Total, other adverse events | 0 / 36 | 0 / 38 |
| serious Total, serious adverse events | 0 / 36 | 0 / 38 |
Outcome results
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.
Time frame: 5 months after baseline
Population: Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taking Care of Us | 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 |
| Taking Care of Us | 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 |
| SUPPORT | Change in Mental Quality of Life Scores in Couples in the TCU vs SUPPORT Condition. | Patients with heart failure | 0.34 units on a scale | Standard Error 1.83 |
| SUPPORT | Change in Mental Quality of Life Scores in Couples in the TCU vs SUPPORT Condition. | Spouse/partner | -0.21 units on a scale | Standard Error 1.84 |
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.
Time frame: 5 months after baseline
Population: Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taking Care of Us | 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 |
| Taking Care of Us | 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 |
| SUPPORT | Change in Physical Quality of Life Scores in Couples in the TCU vs SUPPORT Condition. | Patients with heart failure | -0.03 units on a scale | Standard Deviation 1.51 |
| SUPPORT | Change in Physical Quality of Life Scores in Couples in the TCU vs SUPPORT Condition. | Spouse/partner | -0.63 units on a scale | Standard Deviation 1.92 |
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.
Time frame: 5 months after baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Taking Care of Us | Change in Care Strain Scores in Spouses in the TCU vs SUPPORT Condition. | -1.72 units on a scale | Standard Deviation 5.98 |
| SUPPORT | Change in Care Strain Scores in Spouses in the TCU vs SUPPORT Condition. | 1.32 units on a scale | Standard Deviation 5.57 |
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.
Time frame: 5 months after baseline
Population: Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taking Care of Us | 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 |
| Taking Care of Us | Change in Collaboration Scores in Couples in the TCU vs SUPPORT Condition | Spouse/partner | 1.20 units on a scale | Standard Error 1.65 |
| SUPPORT | Change in Collaboration Scores in Couples in the TCU vs SUPPORT Condition | Patients with heart failure | 0.40 units on a scale | Standard Error 2.29 |
| SUPPORT | Change in Collaboration Scores in Couples in the TCU vs SUPPORT Condition | Spouse/partner | 0.28 units on a scale | Standard Error 1.84 |
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.
Time frame: 5 months after baseline
Population: Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taking Care of Us | 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 |
| Taking Care of Us | 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 |
| SUPPORT | Change in Communication Scores on the Active Engagement Subscale in Couples in the TCU vs SUPPORT Condition | Patients with heart failure | -0.58 units on a scale | Standard Deviation 3.2 |
| SUPPORT | Change in Communication Scores on the Active Engagement Subscale in Couples in the TCU vs SUPPORT Condition | Spouse/partner | 0.74 units on a scale | Standard Deviation 1.91 |
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.
Time frame: 5 months after baseline
Population: Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taking Care of Us | 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 |
| Taking Care of Us | 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 |
| SUPPORT | Change in Communication Scores on the Protective Buffering Subscale in Couples in the TCU vs SUPPORT Condition | Patients with heart failure | 0.05 units on a scale | Standard Deviation 2.12 |
| SUPPORT | Change in Communication Scores on the Protective Buffering Subscale in Couples in the TCU vs SUPPORT Condition | Spouse/partner | 0.42 units on a scale | Standard Deviation 2.22 |
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.
Time frame: 5 months after baseline
Population: Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taking Care of Us | 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 |
| Taking Care of Us | Change in Confidence Scores in Couples in the TCU vs SUPPORT Condition | Spouse/partner | 0.51 units on a scale | Standard Deviation 1.52 |
| SUPPORT | Change in Confidence Scores in Couples in the TCU vs SUPPORT Condition | Patients with heart failure | -0.06 units on a scale | Standard Deviation 1.96 |
| SUPPORT | Change in Confidence Scores in Couples in the TCU vs SUPPORT Condition | Spouse/partner | -0.23 units on a scale | Standard Deviation 2.39 |
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.
Time frame: 5 months after baseline
Population: Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taking Care of Us | 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 |
| Taking Care of Us | 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 |
| SUPPORT | Change in Depressive Symptom Scores in Couples in the TCU vs SUPPORT Condition. | Spouse/partner | -0.40 units on a scale | Standard Deviation 3.64 |
| SUPPORT | Change in Depressive Symptom Scores in Couples in the TCU vs SUPPORT Condition. | Patients with heart failure | -0.74 units on a scale | Standard Deviation 2.71 |
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.
Time frame: 5 months after baseline
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taking Care of Us | 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 |
| Taking Care of Us | 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 |
| SUPPORT | Change in Difference in Dyspnea Scores in the TCU vs SUPPORT Condition | Patients with heart failure | 0.11 units on a scale | Standard Deviation 4.56 |
| SUPPORT | Change in Difference in Dyspnea Scores in the TCU vs SUPPORT Condition | Report of spouse/partner | 0.47 units on a scale | Standard Deviation 5.78 |
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.
Time frame: 5 months baseline
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taking Care of Us | 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 |
| Taking Care of Us | 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 |
| SUPPORT | Change in Difference in Fatigue Scores in Couples in the TCU vs SUPPORT Condition. | Patients with heart failure | -0.21 units on a scale | Standard Deviation 6.76 |
| SUPPORT | Change in Difference in Fatigue Scores in Couples in the TCU vs SUPPORT Condition. | Report of spouse/partner | -0.42 units on a scale | Standard Deviation 6.14 |
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.
Time frame: 5 months after baseline
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taking Care of Us | 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 |
| Taking Care of Us | 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 |
| SUPPORT | Change in Difference in Pain Interference Scores in Couples in the TCU vs SUPPORT Condition | Patients with heart failure | 1.68 units on a scale | Standard Deviation 4.28 |
| SUPPORT | Change in Difference in Pain Interference Scores in Couples in the TCU vs SUPPORT Condition | Report of spouse/partner | 2.47 units on a scale | Standard Deviation 8.61 |
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.
Time frame: 5 months after baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Taking Care of Us | 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 |
| SUPPORT | Change in Heart Failure Related Quality of Life Scores in Persons With Heart Failure in the TCU vs SUPPORT Condition | -0.82 units on a scale | Standard Deviation 15.72 |
Other Pre-specified
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.
Time frame: 5 months after baseline
Population: Data from all those in the Taking Care of Us arm, who complete the 5 month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taking Care of Us | 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 |
| Taking Care of Us | 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 |