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临床试验/NCT06336122
NCT06336122招募中不适用

Older Adults Using Social Support to Improve Self-Care: Adaptation, Implementation, and Feasibility of Peer Support for Older Adults With T2DM in Appalachia.

The University of Texas Medical Branch, Galveston4 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年11月20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
76
试验地点
4
主要终点
Number of participants with change in A1c

研究概览

简要总结

The goal of this clinical trial is to compare the effects of peer coaching models in older adults with unmanaged type two diabetes. The main questions it aims to answer are:

  • Are peer coaching models effective at promoting Type 2 Diabetes Mellitus self-management?
  • If effective, which facets of the peer model are most effective? Peer coaches will undergo peer coach training.
  • Reach out to peer participants on a weekly/biweekly time frame to discuss self-management and goal setting.

Retain records of contact, topics discussed, and general notes on interactions. Researchers will compare differences in the frequency of contact, as well as how peer coaches were matched to peer participants to see if efficacy of the intervention is altered between groups.

详细描述

The Older Adults using Social Support to Improve Self-Care (OASIS) intervention is an asset-based approach, utilizing the unique social structure existing in Kentucky's rural Appalachian communities to address self-care behaviors as they relate to Type 2 Diabetes Mellitus (T2DM) management. The intervention will be composed of two groups: peer coaches who have managed T2DM (HbA1c < 7.5%), and peer participants who have unmanaged T2DM (HbA1c ≥ 7.5%). Peer coaches will undergo training prior to intervention initiation to develop coaching skills. Peer participants will be linked to a peer coach in one of four ways: (1) self-select coach with contact once a week (2) self-selected coach with contact every 2 weeks (3) matched with peer coach with contact once a week (4) matched with peer coach with contact every 2 weeks. In addition to evaluating the effectiveness of a peer coaching model, the four groups will be evaluated allowing for a more detailed understanding of factors that influence self-care behaviors. Stakeholders will also be engaged at three time points: prior to the intervention, study mid-point, and at study conclusion. At study conclusion, a small cohort of both peer participants and peer coaches will be invited to contribute to stakeholder group interviews. Information exchange with stakeholders will aid in developing a robust understanding of influential factors and how to effectively promulgate the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Age greater than or equal to 55 years
  • Resident in Rural Kentucky
  • Positive Diagnosis of Type 2 Diabetes Mellitus
  • HbA1c greater than or equal to 7.5%
  • Passing score on cognitive assessment administered by study personnel
  • English Speaking

排除标准

  • Age less than 55 years
  • Not a resident of a Rural Kentucky County
  • No Type 2 Diabetes Mellitus Diagnosis
  • HbA1c under 7.5%
  • Cognitive Impairment
  • Non-english speaking

研究组 & 干预措施

Peer Participant Group A

Other

Participants will self-select their peer coach and will receive contact once a week.

干预措施: Peer Coach Training - Weekly (Behavioral)

Peer Participant Group B

Other

Participants will self-selected their peer coach and will receive contact every 2 weeks

干预措施: Peer Coach Training - Biweekly (Behavioral)

Peer Participant Group C

Other

Participants will be matched with a peer coach and will receive contact once a week

干预措施: Peer Coach Training - Weekly (Behavioral)

Peer Participant Group D

Other

Participants will be matched with a peer coach and will receive contact every 2 weeks.

干预措施: Peer Coach Training - Biweekly (Behavioral)

结局指标

主要结局

Number of participants with change in A1c

时间窗: Collected at Baseline, 3 month, and 6 month follow up.

Obtained using point of care assessment

次要结局

  • Diabetes Empowerment(Collected at Baseline, 3 month, and 6 month follow up.)
  • Quality of Life Index(Collected at Baseline, 3 month, and 6 month follow up.)
  • Depression Scale(Collected at Baseline, 3 month, and 6 month follow up.)
  • Diabetes Self-Management(Collected at Baseline, 3 month, and 6 month follow up.)
  • Social Support(Collected at Baseline, 3 month, and 6 month follow up.)
  • Problem Areas in Diabetes(Collected at Baseline, 3 month, and 6 month follow up.)
  • Acts of Daily Living(Collected at Baseline, 3 month, and 6 month follow up.)
  • Social Network Scale(Collected at Baseline, 3 month, and 6 month follow up.)

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Brittany L Smalls

Associate Professor

University of Kentucky

研究点 (4)

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