Pilot Trial of Financial Navigation and Peer Support to Improve Diabetes Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- A1c
研究概览
简要总结
The goal of this clinical trial pilot study is to test the feasibility, acceptability, and preliminary efficacy of a combined intervention strategy of 1) technology-supported financial navigation to address economic burden of disease and 2) peer support both to facilitate linkages to clinical care and community resources to address social risks and improve participants' diabetes self-management. The main aims of this pilot study are:
- To examine the feasibility and acceptability of technology-supported financial navigation and financial navigation with peer support
- To examine trends in preliminary efficacy of technology-supported financial navigation and peer support versus financial navigation-alone on 1) A1c and blood pressure (primary outcomes), and 2) out-of-pocket costs, treatment-related financial stress, cost-related non-adherence behaviors, diabetes distress, diabetes self-care behaviors, and uptake of social care assistance (secondary outcomes).
The investigators will assess whether a combined intervention of technology-supported financial navigation and peer support will produce trends in superior diabetes and social care outcomes to financial navigation alone via a 2-arm randomized controlled trial.
Participants will
- Complete 3 survey appointments at baseline, and 3 and 6 months. Each appointment will consist of a survey assessment, an HbA1C test, and two blood pressure readings over the phone.
- Be randomized to either financial navigation only or financial navigation and peer support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants:
- •18-75 years of age
- •diagnosis of diabetes with prescribed anti-hyperglycemic medication
- •most recent (within the past 6 months) recorded hemoglobin A1c (HbA1c) level of ≥7.5% for individuals ≤70 years and >8.0% for individuals between 70-75 years in age
- •positive report of financial burden or cost-related non-adherence (CRN) using screening questions developed and validated from prior work 20-22
- •be willing to provide personal health information in order to effectively participate in the intervention
- •Peer Supporters:
- •International Classification of Diseases (ICD)-10 code for diabetes
- •In the past had A1cs' > 8.0% but whose most recent A1c in the prior 12 months is <8.0%.
- •Past experience with economic burden or unmet social risk factors
- •Adults 18-75 years
排除标准
- •Participants:
- •a diagnosis of a serious psychiatric disorder (e.g., schizophrenia)
- •active alcohol or illicit drug use
- •current pregnancy or planning pregnancy
- •taking a medication that alters glucose metabolism (e.g., oral steroids)
- •report a comorbidity expected to limit life span to < 3 years
- •Participation in another diabetes study, but the investigators will ask them if they would like to be peer supporters
- •Peer Supporters:
- •A diagnosis of a serious psychiatric disorder (e.g., schizophrenia)
- •Active alcohol or illicit drug use
- •Current pregnancy or planning pregnancy
研究组 & 干预措施
Financial Navigation only
Financial navigation using software called TailorMed only. The professional Financial Navigator is from the TailorMed team.
干预措施: Financial Navigation Only (Behavioral)
Financial Navigation and Peer Support
Financial navigation using software called TailorMed combined with peer support. The professional Financial Navigator is from the TailorMed team. Peer Supporters will be trained community members recruited from Michigan Medicine.
干预措施: Financial Navigation and Peer Support (Behavioral)
结局指标
主要结局
A1c
时间窗: From enrollment to the end of participant study duration at 6 months
Collect A1c sample using A1c Now SelfCheck test kit
Blood Pressure
时间窗: From enrollment to the end of participant study duration at 6 months
Measure participant blood pressure using the Omron home blood pressure monitor. Both systolic and diastolic blood pressure will be measured.
次要结局
- Uptake of social care assistance(From enrollment to the end of participant study duration at 6 months)
- Successfully having social/financial need address(From enrollment to the end of participant study duration at 6 months)
- Cost-related non-adherence behaviors(From enrollment to the end of participant study duration at 6 months)
- Out-of-pocket costs(From enrollment to the end of participant study duration at 6 months)
- Diabetes-related social support(From enrollment to the end of participant study duration at 6 months)
- Diabetes self-care behaviors(From enrollment to the end of participant study duration at 6 months)
- Social needs screening(From enrollment to the end of participant study duration at 6 months)
- Diabetes Distress(From enrollment to the end of participant study duration at 6 months)
- Treatment-related financial stress(From enrollment to the end of participant study duration at 6 months)
研究者
Minal Patel
Professor
University of Michigan