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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG068715 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This research study is evaluating the efficacy and feasibility of a novel, dyadic intervention for heart failure couples versus an educational counseling intervention.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taking Care of Us | Behavioral | A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Care Strain Scores in Spouses in the TCU vs SUPPORT Condition. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria: Adults with Heart Failure:
Inclusion Criteria: Spouses/Partners:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen S Lyons, PhD | Boston College | Principal Investigator |
| Christopher S Lee, PhD, RN | Boston College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States | ||
| Boston College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39790834 | Derived | 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. | |
| 36698174 | Derived | Lyons KS, Whitlatch CJ, Vest AR, Upshaw JN, Johnson SH, Morelock J, Lee CS. Taking Care of Us(c) (TCU) study protocol: feasibility and acceptability of a dyadic intervention for couples living with heart failure. Pilot Feasibility Stud. 2023 Jan 25;9(1):16. doi: 10.1186/s40814-023-01249-7. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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18 couples consisting of 18 adults with heart failure and 18 spouse/partners for a total of 36 participants in Taking Care of Us 19 couples consisting of 19 adults with heart failure and 19 spouse/partners for a total of 38 participants in SUPPORT
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | We had 37 couples participate (37 adults with heart failure and 37 spouse/partners) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used. | Posted | Mean | Standard Deviation | units on a scale | 5 months after baseline |
|
5 months (from enrollment until 5 month follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Lyons | Boston College | 6175526379 | karen.lyons@bc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2020 | Jun 10, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| SUPPORT | Other | SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Chestnut Hill |
| Massachusetts |
| 02467 |
| United States |
| spouse dropped when adult with heart failure died |
|
| Lost to Follow-up |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | 37 couples for total of 74 participants (37 patients and 37 partners) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 37 couples | Count of Participants | Participants |
|
| Race (NIH/OMB) | 37 couples (37 patients and 37 partners) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education Level | Number who attended some college | 37 couples (37 patients and 37 partners) | Count of Participants | Participants |
|
| Heart failure severity | Self-reported 1 (can do ordinary physical activities without symptoms); 2 (ordinary physical activities causes symptoms); 3 (less than ordinary physical activity causes symptoms); 4 (experience symptoms at rest). | Only patients self-reported on heart failure severity. | Mean | Standard Deviation | units on a scale |
|
| Financial insecurity | Measure of financial security: 1 (more than enough to make ends meet); 2 (enough to make ends meet); 3 (not enough to make ends meet). Percentage reporting a value of "3" | Self-reported by patients | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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. | Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used. | Posted | Mean | Standard Error | units on a scale | 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. | Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used. | Posted | Mean | Standard Deviation | units on a scale | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 5 months after baseline |
|
|
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. | Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used. | Posted | Mean | Standard Error | units on a scale | 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. | Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used. | Posted | Mean | Standard Deviation | units on a scale | 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. | Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used. | Posted | Mean | Standard Deviation | units on a scale | 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. | Intent to treat: All participants who were assigned to an arm included. Last observation point carried forward (LOCF) imputation method used. | Posted | Mean | Standard Deviation | units on a scale | 5 months after baseline |
|
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| 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. | Data from all those in the Taking Care of Us arm, who complete the 5 month follow-up. | Posted | Mean | Standard Deviation | units on a scale | 5 months after baseline |
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| 2 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | 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. | 0 | 38 | 0 | 38 | 0 | 38 |
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| Male |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Spouse/partner |
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| Spouse/partner |
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| Report of spouse/partner |
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| Report of spouse/partner |
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| Report of spouse/partner |
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| Spouse/partner |
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| Spouse/partner |
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| Spouse/partner |
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| Spouse/partner |
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