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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04737759
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : August 27, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Karen Lyons, Boston College

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.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Taking Care of Us Other: SUPPORT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Taking Care of Us: A Dyadic Intervention for Heart Failure
Actual Study Start Date : July 9, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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

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




Primary Outcome Measures :
  1. 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 [ Time Frame: 5 months after baseline ]
    PROMIS Global Health Short Form measures physical, mental and overall quality of life. Higher scores indicate better quality of life


Secondary Outcome Measures :
  1. 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. [ Time Frame: 5 months after baseline ]
    Center for Epidemiological Studies Depression CESD measure. Lower scores indicate fewer depressive symptoms.

  2. 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. [ Time Frame: 5 months after baseline ]
    Stanford PERC Healthcare Utilization measure collects physician, mental health, emergency room visits and hospitalizations. Lower scores indicate less healthcare utilization.

  3. Change in care strain scores in spouses in the TCU vs SUPPORT condition as assessed by the 16-item Multidimensional Caregiver Strain Index. [ Time Frame: 5 months after baseline ]
    Multidimensional Caregiver Strain Index measures physical, social, interpersonal strain and time constraints and demands related to providing care. Lower scores indicate less strain.

  4. 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. [ Time Frame: 5 months after baseline ]
    Kansas City Cardiomyopathy Questionnaire. Higher scores indicate better heart failure related quality of life.

  5. 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. [ Time Frame: 5 months after baseline ]
    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.

  6. 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. [ Time Frame: 5 months after baseline ]
    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.

  7. Change in difference in fatigue scores in couples in the TCU vs SUPPORT condition as assessed by the 8-item PROMIS Fatigue measure. [ Time Frame: 5 months baseline ]
    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.

  8. Change in collaboration scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item Collaboration in Chronic Illness measure. [ Time Frame: 5 months after baseline ]
    Collaboration in Chronic Illness measure. Higher scores indicate greater collaboration within couples.

  9. 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. [ Time Frame: 5 months after baseline ]
    Stanford Confidence to Manage Chronic Illness measure. Higher scores indicate greater confidence.

  10. Change in communication scores in couples in the TCU vs SUPPORT condition as assessed by the 11-item Dyadic Coping Scale. [ Time Frame: 5 months after baseline ]
    Dyadic Coping Scale. Higher scores indicate greater communication (both active communication and less protective buffering)


Other Outcome Measures:
  1. Change in satisfaction scores in couples in the TCU vs SUPPORT condition as assessed by the Satisfaction and Advantages/Drawbacks measure. [ Time Frame: 5 months after baseline ]
    Satisfaction and Advantages/Drawbacks measure. Higher scores indicate greater satisfaction with assigned program.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04737759


Contacts
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Contact: Karen S Lyons, PhD 617-552-6379 karen.lyons@bc.edu
Contact: Christopher S Lee, PhD, RN 617-552-1804 christopher.lee.8@bc.edu

Locations
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United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Amanda Vest, MD         
Principal Investigator: Amanda Vest, MD         
Sub-Investigator: Jenica Upshaw, MD         
Boston College Recruiting
Chestnut Hill, Massachusetts, United States, 02467
Contact: Karen S Lyons, PhD    617-552-6379    karen.lyons@bc.edu   
Contact: Christopher S Lee, PhD RN    6175521804    christopher.lee.8@bc.edu   
Sponsors and Collaborators
Boston College
National Institute on Aging (NIA)
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Responsible Party: Karen Lyons, Associate Professor, Boston College
ClinicalTrials.gov Identifier: NCT04737759    
Other Study ID Numbers: 21.074
R21AG068715 ( U.S. NIH Grant/Contract )
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karen Lyons, Boston College:
Couples
Spouses
Dyads
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases