Cardiovascular Diseases, Chronic Disease, Chronic Kidney Diseases, Diabetes Mellitus, Type 2, Heart Failure Chronic, Hypertension (HTN), Stroke
Conditions
Keywords
health inequities, rural, dyads, structural determinants of health, quality of life, Social Determinants of Health, Caregivers, Telehealth, Community Health Workers, Social Support, Self-management
Brief summary
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.
Detailed description
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). People from rural regions are more likely to be burdened with greater rates of chronic diseases such as diabetes, hypertension, chronic kidney disease, cardiovascular disease, and stroke. Chronic diseases contribute to more severe health consequences and higher rates of premature mortality. Further, those living in rural areas are also more likely to be impacted by health-related social needs, such as limited health care access, social isolation and lack of social support, that negatively impact quality of life (QoL) and chronic disease self-management behaviors. To provide the fullest health benefits to all people with chronic conditions, it is critical that we design interventions that include strengthening social determinants of health for improved chronic disease self-management, health, functioning, and QoL. This study will utilize an embedded mixed methods design paired with an efficacy RCT. Our iCINGS FAM (Integrating Community-based Intervention Under Nurse Guidance with Families) is a RN-Community Health Worker (CHW)-delivered, telehealth-enhanced intervention (14-weeks) that targets compounding lack of social support (i.e. care network) and stressors for improved chronic illness management and future disease prevention in adult dyads. The objective of iCINGS FAM is to strengthen the efficacy and agency of the dyad to manage illness behaviors as an integrated unit, termed "dyadic illness management."
Interventions
BEHAVIORALIntegrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM)
The 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.
Sponsors
University of South Carolina
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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) -Carepartner inclusion criteria * Male and female * ≥ 18 years and above * Must live on the same property or community, preferably within a 40-mile radius of the patient (dyad member) * Primarily responsible for care provision and/or care/social support in the home (i.e., is not paid for services)
Exclusion criteria
• Enrolled in related clinical trials .No member of dyad has at least one of the included chronic health conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient-reported outcomes measurement information system (PROMIS) Global Health Scale | 0, 4, 7 months | Quality of Life 10 items. minimum score 4 to maximum score 20. Higher scores mean better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PROMIS Short Form v1.0 Anxiety | 0, 4, 7 months. minimum score 6 to maximum score 30. lower scores mean better. | Anxiety 6a (6 items) |
| Change in Center for Epidemiologic Studies Depression Scale (CES-D) | 0, 4, 7 months | Depression 20 items. minimum score 0 to maximum score 60. lower scores mean better. |
| Change in PROMIS Short Form v1.0 Fatigue | 0, 4, 7 months | Fatigue 6a (6 items). minimum score 6 to maximum score 30. lower scores mean better. |
| Change in PROMIS Short From v1.0 Sleep Disturbance | 0, 4, 7 months | Sleep Disturbance 6a (6 items). minimum score 6 to maximum score 30. lower scores mean better. |
| Change in PROMIS Short Form v.1.1 Pain interference | 0, 4, 7 months | Pain interference 8a (8 items). minimum score 8 to maximum score 40. lower scores mean better. |
| Change in Dyadic Illness Management Behaviors | 0, 4, 7 months | Survivor reported Self-care chronic illness Inventory (20 items); Informal carepartner contributions to self-care of chronic illness inventory 20 item |
| Change in Dyadic Efficacy | 0, 4, 7 months. minimum score 10 to maximum score 50. higher scores mean better. | PROMIS v1.0 General Self-efficacy Scale (10 items) |
| Change in Modified Medical Outcomes Study Social Support Survey Instrument (mMOS-SS) | 0, 4, 7 months | Social Support (8 items). Transformed minimum score 0 to maximum score 100. higher scores mean better. |
Countries
United States
Contacts
CONTACTStudy PI
CONTACTProgram Coordinator
PRINCIPAL_INVESTIGATORGayenell S Magwood, PhD
University of South Carolina
Outcome results
None listed