MObile Support Adapted to Individual Contexts (MOSAIC Study)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 547
- 试验地点
- 2
- 主要终点
- Change in Hemoglobin A1c During Intervention Period
研究概览
简要总结
This behavioral clinical trial evaluates an adaptively tailored, mobile phone-delivered intervention (MOSAIC) designed to support adults managing their type 2 diabetes. Adaptive means the intervention can change over time. Tailored means the intervention may be different for different participants. The main questions the study will aim to answer are:
- Does the diabetes education and support delivered via the MOSAIC adaptive mobile phone-delivered intervention improve outcomes more than diabetes education and support delivered via print materials alone? This aim compares the study arms on outcomes such as glycemic management (hemoglobin A1c), diabetes distress, and psychosocial well-being. This aim also compares the study arms on intervention targets (mediators) including diabetes self-efficacy and self-care behaviors.
- For whom does the MOSAIC adaptive tailoring approach improve outcomes more than the print materials alone? This aim examines how well the tailoring rules used for the MOSAIC intervention worked for different participants on the outcomes examined in the first aim.
Participants will enroll in a 16-month study with assessments every 4 months. Assessments include completion of an A1c test and a survey. For those assigned to MOSAIC, they will experience 12-months of mobile phone-delivered support with 3 opportunities for intervention tailoring.
详细描述
MOSAIC intervention components include:
- Monthly coaching sessions (~30 minutes each) - Persons with diabetes (PWD) will engage in goal setting and skill building relevant to their self-identified diet, exercise, and/or stress management goal
- Daily one-way and interactive text messages to support the PWD in meeting their goal and supporting medication adherence
- Weekly interactive text messages asking the PWD to reflect on goal progress followed by personalized feedback from their coach
- The option to invite an adult support person (SP). SPs may be invited to participate in monthly phone coaching and/or receive text messages (3 one-way texts per week and one interactive text per week) pertaining to supporting the PWD, per the MOSAIC intervention adaptive tailoring rules
PWD participants will be randomized in a parallel design to the MOSAIC adaptive mobile phone-delivered intervention or to print materials alone. The study is powered to detect a 0.5% reduction in hemoglobin A1c. Analyses will examine effects during the intervention (4 and 8 months) and post-intervention (12 months) and sustained effects (16 months). Participants will be analyzed as randomized regardless of withdrawal from the intervention (i.e., intention-to-treat principals) and missing data will be imputed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The labs analyzing A1c results (primary outcome, hemoglobin A1c) are masked to the study description or participants' assigned condition.
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 diabetes medication
- •Owns a mobile phone
- •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
MOSAIC
PWD participants will receive MOSAIC components (monthly phone coaching and text message support for goals and medication adherence) for 12 months. PWD participants will receive high-quality print materials upon enrollment and quarterly newsletters on healthy living with diabetes.
All SP participants invited by PWD participants assigned to MOSAIC will receive high-quality print materials upon enrollment and quarterly newsletters on healthy living with diabetes. SPs may participate in monthly phone coaching and/or receive text message support tailored to the goal set by the linked PWD.
干预措施: MOSAIC (Behavioral)
MOSAIC
PWD participants will receive MOSAIC components (monthly phone coaching and text message support for goals and medication adherence) for 12 months. PWD participants will receive high-quality print materials upon enrollment and quarterly newsletters on healthy living with diabetes.
All SP participants invited by PWD participants assigned to MOSAIC will receive high-quality print materials upon enrollment and quarterly newsletters on healthy living with diabetes. SPs may participate in monthly phone coaching and/or receive text message support tailored to the goal set by the linked PWD.
干预措施: Print Materials (Behavioral)
Print Materials
PWD participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on health living with diabetes.
干预措施: Print Materials (Behavioral)
结局指标
主要结局
Change in Hemoglobin A1c During Intervention Period
时间窗: Baseline and 4, 8, and 12 months post-baseline
Hemoglobin A1c assessed by mail-in A1c kits and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic management
Change in Hemoglobin A1c Sustained Post-intervention Effects
时间窗: Baseline and 16 months post-baseline
Hemoglobin A1c assessed by mail-in A1c kits and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic management
次要结局
- Change in Diabetes Distress During Intervention Period(Baseline and 4, 8, and 12 months post-baseline)
- Change in Diabetes Distress Sustained Post-intervention Effect(Baseline and 16 months post-baseline)
- Change in Psychosocial Well-being During Intervention Period(Baseline and 4, 8, and 12 months post-baseline)
- Change in Psychosocial Well-being Sustained Post-intervention Effect(Baseline 16 months post-baseline)
研究者
Lindsay Mayberry
Principal Investigator
Vanderbilt University Medical Center