About this trial
This study tests the efficacy of a dyadic intervention to mitigate the adverse health consequences of adults with pre-existing chronic health conditions and their informal carepartners (IC). Socioeconomically disadvantaged, older, and people from rural regions are more likely burdened with greater rates of chronic diseases such as diabetes, hypertension, chronic kidney disease, cardiovascular disease, and stroke.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male and female
Living in a Medically Underserved Area and/or a designated rural area of South Carolina
≥ 18 years and above
A previous diagnosis of one or more of the following conditions: type 2 diabetes, hypertension, cardiovascular disease, chronic kidney disease, or stroke (>3 months)
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM)
BehavioralThe intervention consists of two planning sessions with the dyad (over 2 weeks) followed by eight topic-guided sessions delivered the RN-CHW team over 12 weeks (weekly the first 4 weeks, then bi-weekly) (Table 3). Key components of these televisits include risk mitigation, chronic disease management, medication adherence, family functioning/support, and community and health systems resource identification and referral with ongoing goal planning. The RN-CHW will meet weekly for progress review, follow up planning, and setting up anticipatory guidance for the next session with the dyads. The RN and CHW will also review IC or survivor dissatisfaction and other issues that require more immediate attention. RN-CHW planning will be assessed to make sure each televisit remain topic focused yet incorporates flexibility to suit the needs of each dyad.
Treatment groups
Trial outcomes
Primary outcomes
Change in patient-reported outcomes measurement information system (PROMIS) Global Health Scale
Quality of Life 10 items. minimum score 4 to maximum score 20. Higher scores mean better.
Secondary outcomes
Change in PROMIS Short Form v1.0 Anxiety
Anxiety 6a (6 items)
Change in Center for Epidemiologic Studies Depression Scale (CES-D)
Depression 20 items. minimum score 0 to maximum score 60. lower scores mean better.
Change in PROMIS Short Form v1.0 Fatigue
Fatigue 6a (6 items). minimum score 6 to maximum score 30. lower scores mean better.
Change in PROMIS Short From v1.0 Sleep Disturbance
Sleep Disturbance 6a (6 items). minimum score 6 to maximum score 30. lower scores mean better.
Sponsors and contacts
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University of South Carolina
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator