SweetMama Usability and Feasibility: Testing of a Novel Technology for Diabetes Education and Support to Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of Participants Who Used the SweetMama Application
研究概览
简要总结
Diabetes during pregnancy is a challenging clinical situation requiring substantial patient engagement. The investigators have developed a novel early-phase tool, called SweetMama, that incorporates educational, motivational and supportive elements to positively impact maternal health behaviors. This phase of work involves develop an optimized version of SweetMama via a 2-step sequential process of in-depth usability and feasibility testing. First the investigators will conduct focus groups and individual usability testing followed by refinement of SweetMama based on participant input. Next, the investigators will conduct feasibility testing via a pilot randomized trial to determine acceptability, feasibility, and pilot procedures for a fully powered larger trial.
详细描述
In prior work, the investigators created a text messaging curriculum that was well-received by patients for diabetes-related education and support during pregnancy. The team has now drawn upon these earlier phases to develop a mobile health behavior tool to educate and support low-income, minority pregnant women with Gestational Diabetes Mellitus and Type 2 Diabetes Mellitus. This "first-of-its-kind" mHealth platform for pregnant women with GDM or T2DM is called SweetMama. SweetMama is a theory-driven application that delivers an interactive, goal-oriented educational and motivational diabetes-focused curriculum. SweetMama currently functions as a user-friendly application in which participants are delivered curriculum messages and have the opportunity to receive novel educational, motivational, or supportive content when desired by patients; they additionally have the opportunity to view library content and receive support with goal-setting.
To perform usability testing, the investigators will first conduct focus groups with 10-20 low-income pregnant women with diabetes to evaluate tool functionality, design, and interpretability. The investigators will then conduct a phase of individual usability testing with 20 women, who will use SweetMama for 2 weeks followed by qualitative (interviews) and quantitative (questionnaires and user interaction data) assessments of tool satisfaction and use.
Next, to perform feasibility testing, the investigators will recruit approximately 40 low-income pregnant women with diabetes to be randomized to either usual care or SweetMama care, from the beginning of their enrollment at this clinical site for diabetes-specific prenatal care through the first 8 weeks postpartum. Randomization will be unbalanced to favor receipt of the intervention. Participants will undergo surveys and interviews at multiple time points, and those who are randomized to experience SweetMama will undergo an exit interview. Outcomes will include retention, treatment adherence, functionality of the tool, and user interactivity with the tool. The expected outcome of the pilot RCT phase is a better understanding of feasibility of a SweetMama trial via field testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 and older
- •Gestational diabetes mellitus or type 2 diabetes mellitus
- •English-speaking
- •Gestational age
- •Focus groups: Confirmed intrauterine pregnancy at least 8 weeks' gestational age or postpartum until 12 weeks after delivery
- •Individual testing: Confirmed intrauterine pregnancy prior to 30 weeks' gestational age
- •Pilot trial: Confirmed intrauterine pregnancy prior to 30 weeks' gestational age
- •Low income, defined as use of publicly-supported insurance for prenatal care or household income <200% of poverty line for family size
- •Access to a mobile smartphone ( for longitudinal testing phase)
排除标准
- •Failure to meet the inclusion criteria above
- •Non-viable pregnancy
结局指标
主要结局
Number of Participants Who Used the SweetMama Application
时间窗: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
Feasibility will be assessed as both ability to recruit and retain participants and as a percentage of active SweetMama use. Feasibility targets for study retention will be set at 80% retention; the feasibility target for SweetMama adoption will be 80% active use (at least weekly interaction with SweetMama content).
Number of Participants Identifying Themes on SweetMama Features
时间窗: 60-90 minutes
Participants completed qualitative group interviews to yield information about SweetMama features and participant preferences after use in the usability laboratory. The identified themes are outlined, and the criteria used to determine the outcome measure is the number of participants who endorsed each theme related to SweetMama features.
次要结局
- Usability Testing of SweetMama Application With the System Usability Scale Survey(After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment))
- Usage Time of SweetMama Application(After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment))
- Patient Activation(After 8 weeks postpartum (approximately 18-38 weeks of enrollment))
- Difference in Hemoglobin A1c From Enrollment to Delivery(After 8 weeks postpartum (approximately 18-38 weeks of enrollment))
- Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire(After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)))
- Diabetes Self-efficacy(After 8 weeks postpartum (approximately 18-38 weeks of enrollment))
- Usability Testing of SweetMama Application With the System Usability Scale Survey(After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment))
- Usage Time of SweetMama Application(After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment))
- Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire(After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)))
- Diabetes Self-efficacy(After 8 weeks postpartum (approximately 18-38 weeks of enrollment))
- Patient Activation(After 8 weeks postpartum (approximately 18-38 weeks of enrollment))
- Difference in Hemoglobin A1c From Enrollment to Delivery(After 8 weeks postpartum (approximately 18-38 weeks of enrollment))