University of South Carolina
Columbia, South Carolina, 29208, United States
Location status: Recruiting
NCT Number: NCT05370014
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Columbia, South Carolina, 29208, United States
Location status: Recruiting
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."
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-Carepartner inclusion criteria
Exclusion criteria
.No member of dyad has at least one of the included chronic health conditions
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.
Time frame: 0, 4, 7 months
Quality of Life 10 items. minimum score 4 to maximum score 20. Higher scores mean better.
Time frame: 0, 4, 7 months. minimum score 6 to maximum score 30. lower scores mean better.
Anxiety 6a (6 items)
Time frame: 0, 4, 7 months
Depression 20 items. minimum score 0 to maximum score 60. lower scores mean better.
Time frame: 0, 4, 7 months
Fatigue 6a (6 items). minimum score 6 to maximum score 30. lower scores mean better.
Time frame: 0, 4, 7 months
Sleep Disturbance 6a (6 items). minimum score 6 to maximum score 30. lower scores mean better.
Time frame: 0, 4, 7 months
Pain interference 8a (8 items). minimum score 8 to maximum score 40. lower scores mean better.
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
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)
Time frame: 0, 4, 7 months
Social Support (8 items). Transformed minimum score 0 to maximum score 100. higher scores mean better.
Contact information is provided by the study sponsor or research team.
University of South Carolina
Other
Improving the Collaborative Health of Adults With Chronic Conditions & Carepartner Dyads Through Interventions Addressing Social and Health Self-Management Needs.
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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