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NCT Number: NCT05370014

Improving the Collaborative Health of Adult Dyads

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.

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Key information

About this study

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."

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in patient-reported outcomes measurement information system (PROMIS) Global Health Scale

    Time frame: 0, 4, 7 months

    Quality of Life 10 items. minimum score 4 to maximum score 20. Higher scores mean better.

Secondary outcomes

  1. Change in PROMIS Short Form v1.0 Anxiety

    Time frame: 0, 4, 7 months. minimum score 6 to maximum score 30. lower scores mean better.

    Anxiety 6a (6 items)

  2. Change in Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: 0, 4, 7 months

    Depression 20 items. minimum score 0 to maximum score 60. lower scores mean better.

  3. Change in PROMIS Short Form v1.0 Fatigue

    Time frame: 0, 4, 7 months

    Fatigue 6a (6 items). minimum score 6 to maximum score 30. lower scores mean better.

  4. Change in PROMIS Short From v1.0 Sleep Disturbance

    Time frame: 0, 4, 7 months

    Sleep Disturbance 6a (6 items). minimum score 6 to maximum score 30. lower scores mean better.

  5. Change in PROMIS Short Form v.1.1 Pain interference

    Time frame: 0, 4, 7 months

    Pain interference 8a (8 items). minimum score 8 to maximum score 40. lower scores mean better.

  6. Change in Dyadic Illness Management Behaviors

    Time frame: 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

  7. Change in Dyadic Efficacy

    Time frame: 0, 4, 7 months. minimum score 10 to maximum score 50. higher scores mean better.

    PROMIS v1.0 General Self-efficacy Scale (10 items)

  8. Change in Modified Medical Outcomes Study Social Support Survey Instrument (mMOS-SS)

    Time frame: 0, 4, 7 months

    Social Support (8 items). Transformed minimum score 0 to maximum score 100. higher scores mean better.

Study contacts

Contact information is provided by the study sponsor or research team.

Program Coordinator

CONTACT

(803) 576-7787

Study PI

CONTACT

[email protected]

8037779160

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Improving the Collaborative Health of Adults With Chronic Conditions & Carepartner Dyads Through Interventions Addressing Social and Health Self-Management Needs.

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 11, 2022
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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