Cardiovascular DiseasesNCT05370014
Improving the Collaborative Health of Adult Dyads
A study testing Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM) in people with Cardiovascular Diseases and Chronic Kidney Diseases, run by University of South Carolina at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus, Type 2
- What is being tested?
- Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM)
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2023to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- ≥ 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)
Who cannot join
- Enrolled in related clinical trials
- .No member of dyad has at least one of the included chronic health conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Program Coordinator contact
United States1 site, 1 recruiting
- Recruiting
University of South Carolina
Columbia, South Carolina, 29208
Gayenell S Magwood, PhD, 8037779160, magwoodg@sc.edu
About this study
Official title: Improving the Collaborative Health of Adults With Chronic Conditions & Carepartner Dyads Through Interventions Addressing Social and Health Self-Management Needs.
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.
Read the 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."
- Conditions
- Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus, Type 2, Chronic Disease, Stroke, Heart Failure Chronic
- Being tested
- Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM)
- 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
- Medical subject headings
- Cardiovascular Diseases, Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Chronic Disease, Stroke, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| iCINGS Fam Intervention | Experimental | 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. Receives: Behavioral: Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM) |
| Attention Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 4, 7 months
Secondary outcomes (8)
Change in PROMIS Short Form v1.0 Anxiety
Anxiety 6a (6 items)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 0, 4, 7 months
Change in Dyadic Efficacy
PROMIS v1.0 General Self-efficacy Scale (10 items)
Measured: 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.
Measured: 0, 4, 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start3 Jan 2023
- Primary completion30 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Gayenell S. Magwood, University of South Carolina
- Investigators
- Gayenell S Magwood, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370014
- Sponsor's protocol ID
- Pro00110062
- Other IDs
- 1R01NR020127
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2022
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scott J, Burrison S, Barron M, Logan A, Magwood GS. Exploring Nursing Strategies to Engage Community in Cardiovascular Care. Curr Cardiol Rep. 2023 Oct;25(10):1351-1359. doi: 10.1007/s11886-023-01949-9. Epub 2023 Sep 4.
PubMed 37665520Magwood GS, Ellis C Jr, Hughes Halbert C, Toussaint EA, Scott J, Nemeth LS. Exploring Barriers to Effective COVID-19 Risk Mitigation, Recovery, and Chronic Disease Self-Management: A Qualitative Multilevel Perspective. Patient Relat Outcome Meas. 2024 Sep 18;15:241-253. doi: 10.2147/PROM.S467743. eCollection 2024.
PubMed 39310085