跳至主要内容
临床试验/NCT05370014
NCT05370014招募中不适用

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

University of South Carolina2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年1月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
2
主要终点
Change in patient-reported outcomes measurement information system (PROMIS) Global Health Scale

研究概览

简要总结

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.

详细描述

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."

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • Enrolled in related clinical trials
  • .No member of dyad has at least one of the included chronic health conditions

研究组 & 干预措施

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.

干预措施: Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM) (Behavioral)

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.

结局指标

主要结局

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

时间窗: 0, 4, 7 months

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

次要结局

  • Change in PROMIS Short From v1.0 Sleep Disturbance(0, 4, 7 months)
  • Change in PROMIS Short Form v.1.1 Pain interference(0, 4, 7 months)
  • Change in Dyadic Illness Management Behaviors(0, 4, 7 months)
  • Change in PROMIS Short Form v1.0 Anxiety(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)(0, 4, 7 months)
  • Change in PROMIS Short Form v1.0 Fatigue(0, 4, 7 months)
  • Change in Dyadic Efficacy(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)(0, 4, 7 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gayenell S. Magwood

Professor

University of South Carolina

研究点 (2)

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