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

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Taking Care of Us

SUPPORT

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Couples, Spouses, Dyads

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Tufts Medical Center
Boston College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Taking Care of Us

SUPPORT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in quality of life scores in couples in the TCU vs SUPPORT condition assessed by the 10-item PROMIS Global Health Short Form measure

PROMIS Global Health Short Form measures physical, mental and overall quality of life. Higher scores indicate better quality of life

Secondary Outcome Measures

Change in depressive symptom scores in couples in the TCU vs SUPPORT condition as assessed by the 20-item Center for Epidemiological Studies Depression CESD measure.

Center for Epidemiological Studies Depression CESD measure. Lower scores indicate fewer depressive symptoms.

Change in healthcare utilization scores in couples in the TCU vs SUPPORT condition as assessed by the 5-item Stanford Patient Education Research Center PERC Healthcare Utilization measure.

Stanford PERC Healthcare Utilization measure collects physician, mental health, emergency room visits and hospitalizations. Lower scores indicate less healthcare utilization.

Change in care strain scores in spouses in the TCU vs SUPPORT condition as assessed by the 16-item Multidimensional Caregiver Strain Index.

Multidimensional Caregiver Strain Index measures physical, social, interpersonal strain and time constraints and demands related to providing care. Lower scores indicate less strain.

Change in heart failure related quality of life scores in persons with heart failure in the TCU vs SUPPORT condition as assessed by the 12-item Kansas City Cardiomyopathy Questionnaire.

Kansas City Cardiomyopathy Questionnaire. Higher scores indicate better heart failure related quality of life.

Change in difference in dyspnea scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item Heart Failure Somatic Perception Scale.

Difference in scores is measured by comparing the scores of both the person with heart failure and their spouse. Scores closer to zero indicate less difference.

Change in difference in pain interference scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item PROMIS Pain Interference measure.

Difference in scores is measured by comparing the scores of both the person with heart failure and their spouse. Scores closer to zero indicate less difference.

Change in difference in fatigue scores in couples in the TCU vs SUPPORT condition as assessed by the 8-item PROMIS Fatigue measure.

Difference in scores is measured by comparing the scores of both the person with heart failure and their spouse. Scores closer to zero indicate less difference.

Change in collaboration scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item Collaboration in Chronic Illness measure.

Collaboration in Chronic Illness measure. Higher scores indicate greater collaboration within couples.

Change in confidence scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item Stanford Confidence to Manage Chronic Illness measure.

Stanford Confidence to Manage Chronic Illness measure. Higher scores indicate greater confidence.

Change in communication scores in couples in the TCU vs SUPPORT condition as assessed by the 11-item Dyadic Coping Scale.

Dyadic Coping Scale. Higher scores indicate greater communication (both active communication and less protective buffering)

Full Information

NCT ID

NCT04737759

First Posted

January 27, 2021

Last Updated

July 25, 2023

Sponsor

Boston College

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT04737759

Brief Title

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

Acronym

TCU

Official Title

Taking Care of Us: A Dyadic Intervention for Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

July 9, 2021 (Actual)

Primary Completion Date

May 31, 2023 (Actual)

Study Completion Date

May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston College

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Couples, Spouses, Dyads

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Taking Care of Us

Arm Type

Experimental

Arm Description

Arm Title

SUPPORT

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Taking Care of Us

Intervention Description

A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.

Intervention Type

Other

Intervention Name(s)

SUPPORT

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in quality of life scores in couples in the TCU vs SUPPORT condition assessed by the 10-item PROMIS Global Health Short Form measure

Description

PROMIS Global Health Short Form measures physical, mental and overall quality of life. Higher scores indicate better quality of life

Time Frame

5 months after baseline

Secondary Outcome Measure Information:

Title

Change in depressive symptom scores in couples in the TCU vs SUPPORT condition as assessed by the 20-item Center for Epidemiological Studies Depression CESD measure.

Description

Center for Epidemiological Studies Depression CESD measure. Lower scores indicate fewer depressive symptoms.

Time Frame

5 months after baseline

Title

Change in healthcare utilization scores in couples in the TCU vs SUPPORT condition as assessed by the 5-item Stanford Patient Education Research Center PERC Healthcare Utilization measure.

Description

Stanford PERC Healthcare Utilization measure collects physician, mental health, emergency room visits and hospitalizations. Lower scores indicate less healthcare utilization.

Time Frame

5 months after baseline

Title

Change in care strain scores in spouses in the TCU vs SUPPORT condition as assessed by the 16-item Multidimensional Caregiver Strain Index.

Description

Multidimensional Caregiver Strain Index measures physical, social, interpersonal strain and time constraints and demands related to providing care. Lower scores indicate less strain.

Time Frame

5 months after baseline

Title

Change in heart failure related quality of life scores in persons with heart failure in the TCU vs SUPPORT condition as assessed by the 12-item Kansas City Cardiomyopathy Questionnaire.

Description

Kansas City Cardiomyopathy Questionnaire. Higher scores indicate better heart failure related quality of life.

Time Frame

5 months after baseline

Title

Change in difference in dyspnea scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item Heart Failure Somatic Perception Scale.

Description

Difference in scores is measured by comparing the scores of both the person with heart failure and their spouse. Scores closer to zero indicate less difference.

Time Frame

5 months after baseline

Title

Change in difference in pain interference scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item PROMIS Pain Interference measure.

Description

Difference in scores is measured by comparing the scores of both the person with heart failure and their spouse. Scores closer to zero indicate less difference.

Time Frame

5 months after baseline

Title

Change in difference in fatigue scores in couples in the TCU vs SUPPORT condition as assessed by the 8-item PROMIS Fatigue measure.

Description

Difference in scores is measured by comparing the scores of both the person with heart failure and their spouse. Scores closer to zero indicate less difference.

Time Frame

5 months baseline

Title

Change in collaboration scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item Collaboration in Chronic Illness measure.

Description

Collaboration in Chronic Illness measure. Higher scores indicate greater collaboration within couples.

Time Frame

5 months after baseline

Title

Change in confidence scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item Stanford Confidence to Manage Chronic Illness measure.

Description

Stanford Confidence to Manage Chronic Illness measure. Higher scores indicate greater confidence.

Time Frame

5 months after baseline

Title

Change in communication scores in couples in the TCU vs SUPPORT condition as assessed by the 11-item Dyadic Coping Scale.

Description

Dyadic Coping Scale. Higher scores indicate greater communication (both active communication and less protective buffering)

Time Frame

5 months after baseline

Other Pre-specified Outcome Measures:

Title

Change in satisfaction scores in couples in the TCU vs SUPPORT condition as assessed by the Satisfaction and Advantages/Drawbacks measure.

Description

Satisfaction and Advantages/Drawbacks measure. Higher scores indicate greater satisfaction with assigned program.

Time Frame

5 months after baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Boston College

City

Chestnut Hill

State/Province

Massachusetts

ZIP/Postal Code

02467

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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