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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
74
A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
Tufts Medical Center
Boston, Massachusetts, United States
Boston College
Chestnut Hill, Massachusetts, United States
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
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
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
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
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
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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
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
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
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
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
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
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