调整 FAMS 以优化患有 1 型糖尿病的新兴成人的 CGM 使用
The goal of this clinical trial is to evaluate the efficacy of an adapted FAMS (Family/friend Activation to Motivate Self-care) intervention on CGM use among study participants who are CGM users. We will leverage the infrastructure of an NIDDK-funded RCT evaluating FAMS-T1D among N=280 emerging adults with T1D who have elevated hemoglobin A1c or elevated diabetes distress (NCT05820477). We anticipate at least 50% using CGM to be included in these analyses.
研究概览
详细说明
FAMS (Family/friend Activation to Motivate Self-care) is a mobile phone-delivered intervention, based on Family Systems Theory, which helps adults with diabetes set behavioral goals and improve support received from friends and family for goal success. FAMS includes monthly phone coaching and text message support by FAMS coaches for the person with diabetes (PWD) and the option to enroll a support person (SP) to receive automated texts tailored to the self-care goals the person with T1D sets in coaching sessions. Adaptations specific to CGM include the option to set CGM use goals in coaching (and receive associated text support) and skill-building exercises during coaching to support data sharing relationships (e.g., establishing, setting and adjusting ground rules about communication).
Within the FAMS-T1D RCT (NCT05820477), we will test effects of FAMS-T1D on CGM use use relative to enhanced treatment as usual. We will evaluate effects on CGM use from baseline to post-intervention (6 months) as the primary endpoint. Study start date for the nested trial (NCT05854069) is the enrollment date of the first participant using a CGM. Since the goal of this trial is to assess effects of the adapted FAMS intervention on CGM use, the date participant CGM usage was confirmed is considered the enrollment date.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
California
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Los Angeles、California、美国、90027
- Children's Hospital of Los Angeles
-
-
Utah
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Salt Lake City、Utah、美国、84112
- University of Utah
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
PERSONS WITH DIABETES
- Ages 18-24
- Have a diagnosis of T1D and has been taking insulin for at least one year
- Comfortable sending and receiving texts
- Can speak, read, and write in English
- Meets one of the following two criteria: 1) has a most recent A1c value in the EHR that is 7.5% or higher (or missing) OR 2) screen positive for diabetes distress on the two-item Diabetes Distress Screen (DDS-2)
- Using a continuous glucose monitor (CGM)
SUPPORT PERSONS
- Age 18 or older
- Can speak, read, and write in English or Spanish
- Comfortable sending and receiving texts
Exclusion Criteria:
PERSONS WITH DIABETES
- Has a condition that would prohibit study completion (intellectual disability, blindness or auditory limitations, severe mental illness)
- Plans to live outside the country during the study period
SUPPORT PERSONS
- Shares a phone with the person with diabetes
- Plans to live outside of the country during the study period
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：FAMS-T1D
Participants will receive FAMS-T1D components (monthly phone coaching and text message support for goals) for 6 months. Support persons will receive text messages that are tailored to the goal set by the person with type 1 diabetes. All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes. |
FAMS-T1D involves monthly phone coaching that assists individuals in setting specific and time bound diabetes goals with automated text message support to the patient participant and less frequent automated text messages to their support person, if one is enrolled. Behavioral: Diabetes Resources High quality digital materials about diabetes management will be provided upon enrollment and send to participants quarterly.
其他名称：
Quality digital resources about diabetes management provided upon enrollment and during the study. |
|
安慰剂比较：Digital resources for diabetes
All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes. |
Quality digital resources about diabetes management provided upon enrollment and during the study. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
CGM frequency of use during the intervention period
大体时间：Baseline and 6 months post-baseline
|
Change in CGM frequency of use assessed by self-report on questionnaire; more frequent use/higher is better |
Baseline and 6 months post-baseline
|
|
CGM frequency of use during the intervention period
大体时间：Baseline and 6 months post-baseline
|
Change in CGM frequency of use assessed by objective CGM data (% of time; higher is better) |
Baseline and 6 months post-baseline
|
|
Gaps in CGM use
大体时间：6 months post-baseline
|
Length of gaps in CGM use as assessed by objective CGM data (measured in number of consecutive days without CGM data; higher is worse) |
6 months post-baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
CGM behavioral responses during the intervention period
大体时间：Baseline and 6 months post-baseline
|
Change in frequency of making behavioral changes in response to CGM data assessed by self-report; higher scores indicate more frequent response (better) |
Baseline and 6 months post-baseline
|
|
Barriers to CGM use during the intervention period
大体时间：Baseline and 6 months post-baseline
|
Change in perceived influence of CGM on glycemic control scale assessed by Glucose Monitoring Survey; higher scores indicate more perceived problems with CGM use (worse) |
Baseline and 6 months post-baseline
|
|
Barriers to CGM use during the intervention period
大体时间：Baseline and 6 months post-baseline
|
Change in perceived influence of CGM on social complications assessed by Glucose Monitoring Survey; higher scores indicate more perceived problems with CGM use (worse) |
Baseline and 6 months post-baseline
|
|
CGM satisfaction during the intervention period
大体时间：Baseline and 6 months post-baseline
|
Change in CGM satisfaction assessed by Benefits of CGM scale; higher scores indicate more perceived benefits of CGM use (better) |
Baseline and 6 months post-baseline
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Data sharing during the intervention period
大体时间：6 months post-baseline
|
Number of data sharing relationships, between groups; more is better |
6 months post-baseline
|
|
Satisfaction with data-sharing relationships
大体时间：6 months post-baseline
|
Satisfaction with data-sharing relationships assessed by CGM-Satisfaction Scale; higher scores are better |
6 months post-baseline
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 220847
- G-2203-05822 (其他赠款/资助编号：The Leona M. and Harry B. Helmsley Charitable Trust)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigator.
IPD 共享时间框架
After study results are posted on clinical trials and outcomes published in a peer-reviewed journal, until 5 years later.
IPD 共享访问标准
Contact the principal investigator
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
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