Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- Change in Glucose Control (Stage 1: Usual Care v. Peer Mentoring)
研究概览
简要总结
The purpose of this study is to test the effectiveness of a peer mentor model in a mixed race population of poorly controlled diabetic Veterans. Also, the study aims to assess the effects of becoming a mentor on those who originally were mentees. It is expected that participants in the peer mentoring arms (Arm 2 and 3) will have improved glucose control regardless of race or ethnicity at the end of the intervention.
详细描述
The primary objectives of this study are: (1) test the long-term effectiveness of a peer mentor model on improving glucose control, blood pressure, LDL levels, diabetes mellitus quality of life, and depression scores in a mixed race population of poorly controlled diabetic Veterans; (2) test the effectiveness of using former peer mentees as peer mentors as a means of creating a self-sustaining program; and (3) and test the effects of becoming a mentor on those who were originally mentees given a growing literature that being a mentor is good for your health. Secondary objectives include: (1) in those randomized to being a mentee, explore mentor characteristics associated with improved HbA1c.
This study will be a prospective randomized controlled trial. Outcomes to be measured include glycosylated hemoglobin, blood pressure, direct LDL, diabetes quality of life and depression.
The trial has two phases. In phase one, patients with poorly controlled diabetes are randomized to usual care or receiving peer mentoring. In phase two, poorly controlled diabetics are randomized to usual care or receiving peer mentoring from former mentees. Former mentees from phase 1 are also randomized such that they will have a 50% chance of becoming a mentor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •All participants must have a diagnosis of Type 2 diabetics.
- •Diabetes began after age 30
- •Mentees: Have an HbA1c > 8% on 2 different occasions in the course of 24 months, with at least one measure within 3 months of enrollment
- •Mentors for Phase 1: Had an HbA1c of > 8% in the past 3 years and an HbA1c < (or equal to) 7.5% within 3 months of enrollment
- •Mentors for Phase 2: Former mentee
排除标准
- •Exclusion Criteria:
- •Does not speak English
- •Unable to understand consents
- •Severe speech impediment
- •over the age of 75
研究组 & 干预措施
Usual Care
Enrolled in two different time frames. No interventions will be provided to this arm. They will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).
Peer Mentoring
Participants in this arm will be mentored for 6 months by a veteran who was once in poor control but is now in good control. They will then be further randomized to either becoming a mentor for 6 months or having no other additional active intervention. All participants in this arm will be evaluated in person at baseline, 6 months, 12 months, and 18 months.
干预措施: Peer Mentoring (Behavioral)
Peer Mentoring FFM (from former mentee)
Participants in this arm will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
干预措施: Peer Mentoring (Behavioral)
结局指标
主要结局
Change in Glucose Control (Stage 1: Usual Care v. Peer Mentoring)
时间窗: Baseline to 6 months
Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)
Change in Glucose Control (Stage 2: Usual Care v. Mentees)
时间窗: Baseline to 6 months
Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)
Change in Glucose Control (Stage 2: Non-mentors v. Mentors)
时间窗: Baseline to 6 months
Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)
次要结局
- Change in Direct LDL Blood Levels(Baseline to 12 months)
- Change in Systolic Blood Pressure(Baseline to 12 months)
- Change in Diabetes Quality of Life Score(Baseline to 6 months)
- Change in Depression Symptoms(Baseline to 12 months)
- Change in Glucose Control(Baseline to 12 months)
- Change in Diabetes Quality of Life(Baseline to 12 months)
- Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees)(Baseline to 12 months)
- Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee)(Baseline to 12 months)
- Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee)(Baseline to 12 months)
- Change in Depression Symptoms (Stage 2: Usual Care v. Mentees)(Baseline to 12 months)
- Change in Glucose Control (Stage 2: Usual Care v. Mentees)(Baseline to 12 months)
- Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors)(Baseline to 12 months)
- Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors)(Baseline to 12 months)
- Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors)(Baseline to 12 months)
- Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors)(Baseline to 12 months)
- Change in Glucose Control (Stage 2: Non-mentors v. Mentors)(Baseline to 12 months)