STrong Relationships to Improve DiabEtes (STRIDE) Pilot
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
This is a pilot and feasibility study for a mobile phone-delivered intervention, called STRIDE (STrong Relationships to Improve DiabEtes), designed to provide support for adults with type 2 diabetes (improve glycemic management and social support). The goal of the study is to examine the feasibility and acceptability of STRIDE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •PERSONS WITH DIABETES:
- •Speaks and reads in English
- •18-75 years old
- •Diagnosed with type 2 diabetes
- •Receiving outpatient care from a partnering clinic
- •Community-dwelling (e.g., not in a nursing facility)
- •Prescribed at least one daily diabetes medication
- •Owns a mobile phone
- •Elevated diabetes distress or low diabetes self-efficacy
- •Willing to invite a close friend or family member to co-participate
- •SUPPORT PERSONS:
- •Speaks and reads in English
- •18 years or older
- •Owns a mobile phone
排除标准
- •PERSONS WITH DIABETES
- •Unable to communicate by phone
- •Currently pregnant
- •Currently undergoing treatment for cancer (e.g., radiation, chemotherapy)
- •Diagnosed with end-stage renal disease
- •Receiving hospice services
- •Diagnosed with congestive heart failure
- •Diagnosed with dementia
- •Diagnosed with schizophrenia
- •Demonstrated an inability to receive and respond to a text
- •Does not take medication on his/her own/medication administered by someone else SUPPORT PERSONS
- •Demonstrated inability to receive & respond to a text
- •Unable to communicate by phone
研究组 & 干预措施
Experimental: Step 1: Optimal First Line Treatment
Persons with diabetes (PWD) participants will first be randomized to an optimal first line treatment in order to compare FAMS vs. PEER. PWD participants assigned to Step 1 treatment "FAMS" will have the option to co-enroll a friend/family member as a support person (SP) to receive text message support tailored to the goal set by the linked PWD. PWD participants assigned to Step 1 treatment "PEER" will be paired with another participant to provide each other peer support.
干预措施: FAMS (Behavioral)
Experimental: Step 1: Optimal First Line Treatment
Persons with diabetes (PWD) participants will first be randomized to an optimal first line treatment in order to compare FAMS vs. PEER. PWD participants assigned to Step 1 treatment "FAMS" will have the option to co-enroll a friend/family member as a support person (SP) to receive text message support tailored to the goal set by the linked PWD. PWD participants assigned to Step 1 treatment "PEER" will be paired with another participant to provide each other peer support.
干预措施: PEER (Behavioral)
Experimental: Step 2: Optimal Second Line Treatment
All PWD participants will be randomized at month 3 to FAMS or PEER. PWD participants assigned to Step 2 treatment "FAMS" will have the option to co-enroll a friend/family member as a support person (SP) to receive text message support tailored to the goal set by the linked PWD if not previously enrolled. PWD participants assigned to Step 2 treatment "PEER" will be paired with another participant to provide each other peer support. If they had previously enrolled a SP, the SP participant will stop receiving text messages.
干预措施: FAMS (Behavioral)
Experimental: Step 2: Optimal Second Line Treatment
All PWD participants will be randomized at month 3 to FAMS or PEER. PWD participants assigned to Step 2 treatment "FAMS" will have the option to co-enroll a friend/family member as a support person (SP) to receive text message support tailored to the goal set by the linked PWD if not previously enrolled. PWD participants assigned to Step 2 treatment "PEER" will be paired with another participant to provide each other peer support. If they had previously enrolled a SP, the SP participant will stop receiving text messages.
干预措施: PEER (Behavioral)
结局指标
主要结局
Acceptability
时间窗: 6 months post-baseline
Net Promoter Score with scores ranging 0 to 100 where higher scores (scaled score \>0) indicate good acceptability
Feasibility (Treatment Adherence)
时间窗: 6 months post-baseline
Proportion of sessions attended
Feasibility (Recruitment)
时间窗: baseline
Number of participants screened/week
Feasibility (Assessment Completion)
时间窗: 3 and 6 months post-baseline
Proportion of self-report measures completed
次要结局
- Change in Hemoglobin A1c(Baseline and 3 and 6 months post-baseline)
- Change in Diabetes Distress(Baseline and 3 and 6 months post-baseline)
- Change in Psychosocial Well-being(Baseline and 3 and 6 months post-baseline)
- Change in Social Support for Diabetes(Baseline and 3 and 6 months post-baseline)
研究者
McKenzie Roddy
Assistant Professor
Vanderbilt University Medical Center