Improving the Collaborative Health of Adult Dyads

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of South Carolina

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

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

    Behavioral

    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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: iCINGS Fam InterventionExperimental treatment 1 intervention
Group B: Attention ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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.
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of South Carolina

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator