An interventional study of Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM) in Cardiovascular Diseases, Chronic Kidney Diseases and Diabetes Mellitus, Type 2, sponsored by University of South Carolina. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by University of South Carolina · Not applicable, Interventional, and Supportive care
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.
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."
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 500 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of South Carolina is the lead sponsor of 197 studies on the registry; 42 are open to participants now.
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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
Exclusion Criteria:
.No member of dyad has at least one of the included chronic health conditions
Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM) is 14-week, nurse coordinated, Community Health Worker (CHW) supported telehealth intervention structure. After baseline assessment, dyads randomized to the intervention group (n= 125 dyads) will have two planning sessions (over 2 weeks) followed by eight topic-guided sessions delivered by a member of the RN-CHW team over 12 weeks (weekly the first 4 weeks, then bi-weekly), Follow up assessments will occur at month 4 and month 7.
Behavioral: Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM)
After baseline assessment, dyads randomized to the attention control group (n= 125 dyads) will receive monthly (3 in total; 7-10 min each) scripted phone calls on focused on general health risks and health promotion. Monthly pre-recorded messages will cover readily accessible evidence-based public health messaging from the Centers for Disease Control and Prevention (CDC) Your Health, NIH and other public health community facing websites related to risk reduction and prevention strategies including flu vaccines, asymptomatic spread, and contact tracing. Follow up assessments will occur at month 4 and month 7.
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.
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.
Time frame: 0, 4, 7 months
Change in PROMIS Short Form v1.0 Anxiety
Anxiety 6a (6 items)
Time frame: 0, 4, 7 months. minimum score 6 to maximum score 30. lower scores mean better.
Change in Center for Epidemiologic Studies Depression Scale (CES-D)
Depression 20 items. minimum score 0 to maximum score 60. lower scores mean better.
Time frame: 0, 4, 7 months
Change in PROMIS Short Form v1.0 Fatigue
Fatigue 6a (6 items). minimum score 6 to maximum score 30. lower scores mean better.
Time frame: 0, 4, 7 months
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.
Time frame: 0, 4, 7 months
Change in PROMIS Short Form v.1.1 Pain interference
Pain interference 8a (8 items). minimum score 8 to maximum score 40. lower scores mean better.
Time frame: 0, 4, 7 months
Change in Dyadic Illness Management Behaviors
Survivor reported Self-care chronic illness Inventory (20 items); Informal carepartner contributions to self-care of chronic illness inventory 20 item
Time frame: 0, 4, 7 months
Change in Dyadic Efficacy
PROMIS v1.0 General Self-efficacy Scale (10 items)
Time frame: 0, 4, 7 months. minimum score 10 to maximum score 50. higher scores mean better.
Change in Modified Medical Outcomes Study Social Support Survey Instrument (mMOS-SS)
Social Support (8 items). Transformed minimum score 0 to maximum score 100. higher scores mean better.
Time frame: 0, 4, 7 months
Plan to share: No
Started Jan 2023 (actual). Primary completion is estimated for May 2027, 52 months after the start.
Of 1,077 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 52 months is above that.
Counting every sponsor, half of 1,216 studies reached it within 26 months; a quarter within 12 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
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