Recruiting

Observational Study

Sponsor:

University of South Carolina

Code:

NCT05370014

Conditions

Cardiovascular Diseases

Chronic Kidney Diseases

Diabetes Mellitus, Type 2

Chronic Disease

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM)

Study Details

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.

Conditions

Cardiovascular Diseases

Chronic Kidney Diseases

Diabetes Mellitus, Type 2

Chronic Disease

Stroke

Study ID

NCT05370014

Start date

Jan 3, 2023

Status verified date

Sep, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: iCINGS Fam Intervention

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.

no intervention: Attention Control

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.

Interventions

Integrating 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.

Primary outcome measure

  • Change in patient-reported outcomes measurement information system (PROMIS) Global Health Scale [ Time Frame: 0, 4, 7 months ]

Central Contacts and Locations

Central contacts

Study PI

8037779160magwoodg@sc.edu

Program Coordinator

(803) 576-7787

Locations

University of South Carolina

Recruiting

Columbia, South Carolina, United States, 29208

Contacts

Gayenell S Magwood, PhD

8037779160magwoodg@sc.edu

More Information

Sponsor

University of South Carolina

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of South Carolina on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.