Financial Incentives and SMS to Improve African American Womens' Glycemic Control: Friends & Relatives Improving the Effectiveness of Networks for Diabetes Support Through Text Messaging (FRIENDS Text)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change from Baseline in Hemoglobin A1c at 12-months
研究概览
简要总结
Diabetes is a major public health problem that is associated with substantial health disparities for African American women compared to African American men or white men and women. This project will incorporate a) new technology whose use is high among African Americans (cell phone text message reminders), b) support from social networks, and c) strategies from the emerging field of behavioral economics to encourage and support self care behaviors that lead to improvements in diabetes control.
In Stage I of the study, the investigators conducted focus groups with women with diabetes and their family members and friends. The investigators used information from these groups to work with a team of community partners to develop recruitment protocols, prepare study documents (including flyers, Frequently Asked Questions sheets, and informed consent forms), and finalize participant surveys.
In the next phase of the study the investigators will evaluate ways that friends and family members can use direct support and text messages to improve control of blood sugar for African American women with type 2 diabetes. A team of three people--the Person With Diabetes (PWD) and 2 friends or family members, also known as the Support Team Members (STMs)--will be assigned at random to one of two groups to compare approaches to improving control of blood sugar. Each team will receive information and resources on improving diabetes control and will be linked by a text messaging program. The intervention team will receive additional text messaging support that may help them improve the PWD's diabetes control.
详细描述
Control Condition. Control group participants will consist of the person with diabetes (PWD) and their two support team members (STMs). The PWD will receive regular medical care from their usual providers. They will also receive an introductory educational session and written materials on diabetes, the importance of its control, and diabetes self-care strategies, and a blood glucose and physical activity monitoring log. They will be invited for study visits, distinct from their routine clinic visits, at 3, 6, and 12 months to measure cholesterol, A1c (for those with diabetes), blood pressure, height, and weight measurement. Participants in the control condition will receive generic health promotion information during in-person visits or by mail. They will receive follow-up messages by text to remind them about study related events.
Intervention Group. Participants in the intervention condition will consist of the PWD and their two STMs. The PWD will receive the same protocols that the "Usual Care" participants receive, including an introductory educational session, written materials on diabetes, a blood glucose log, and a physical activity monitoring log.
The PWDs in the intervention group will receive training in action planning that is linked to their role self-identity. Role identity will be kept highly salient throughout the study by using identity primes that remind the individual that both processes (diabetes self-care behaviors) and goals (achieving A1c targets) are important responsibilities associated with that role. For example, participants may be asked to keep a picture or memento that reminds them of their role identity (e.g., a picture of a child or a photo of a place she would like to visit) on a blood sugar and physical activity log that the study will provide to the patient. The STMs in the intervention group will discuss these role identities and motivators with the PWD in their team intake session. They will also obtain similar training in action planning and in ways to support the PWD in order to better control her diabetes.
Intervention team members will be reminded of the PWD's intrinsic motivations (IM), and how engaging in regular diabetes self-care can improve diabetes control, during interactions designed to boost the participants' confidence that they can accomplish and sustain the behavior change that contributes to interim and longer term goals. These interactions include text messages between the support team and the study team and between members of the support team. The text messages will include individually- and/or culturally-tailored messages, some of which are linked to the motivating factors identified through the questionnaire and probes. The text messages will take varying forms: (a) General diabetes messages derived from sources such as the ADA African American Programs and the National Diabetes Education Program; (b) Reminders about blood glucose monitoring, medication adherence, diet, and exercise, and how these behaviors contribute to maintaining role identity; (c) Prompts or queries about home glucose monitor readings and their frequencies that allow participants to communicate by text with study staff on non-urgent matters; and (d) Challenges and contests for which they receive supportive text messages.
Face-to-Face Meetings will occur at the baseline and months 3, 6, and 12 to gather study data. For the intervention group, this will also include contact with a study team member who helps the intervention PWD and STMs identify and agree to desired behaviors and A1c targets. The study team member will review glucometer readings, medication refills, and A1c levels; encourage each PWD to engage in processes (e.g., self-monitoring or adhering to medications); encourage STMs in their supportive roles; congratulate those PWDs who near or reach A1c targets; and motivate those having difficulty reaching their targets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Eligible persons with diabetes (PWDs) will be identified either through the clinic diabetes registry, referrals from their providers, or direct recruitment by study staff during clinic hours. Eligible subjects are African American women seen at the clinic at least once in the prior 12 months, who have a record of at least one A1c reading in the past year (most recent A1c >8%), indicate that they plan to receive their diabetes care from the clinic over the next 18 months, and have a cell phone with an active plan, have two other individuals who they identify as friends or family members to enroll with them.
- •Eligible support team members (STMs) will be identified by the PWD as being a friend or family member 18 years or older and have a cell phone with an active plan.
- •To enroll in the study, there must be a triad (1 PWD and 2 STMs) that meet all study inclusion requirements. After the study begins, if one of the STMs drops out/withdrawals from the study, the team can continue to participate. However, if the PWD drops out/withdrawals from the study, the team will not be able to continue in the study and therefore, will be dropped from the study by the principal investigator.
排除标准
- •The investigators will exclude PWDs who are pregnant at the time of enrollment or those who only had diabetes during pregnancy, children, prisoners, homeless persons, institutionalized adults, and adults with type 1 diabetes, hemophilia, AIDS, cancer, hemoglobinopathies, or severe mental illness.
- •The investigators will exclude STMs who are younger than 18 years old or do not have a cell phone with an active plan.
结局指标
主要结局
Change from Baseline in Hemoglobin A1c at 12-months
时间窗: 12-months
The investigators will measure the change in hemoglobin A1c (measured as % A1c).
次要结局
- Change from Baseline in Waist Circumference (inches) at 12-months(12 months)
- Change from Baseline in Body Mass Index at 12-months(12 months)
- Change from Baseline in Systolic and Diastolic Blood Pressure at 12-months(12 months)
- Change from Baseline in Weight 12-months(12 months)
研究者
Arleen F. Brown, MD, PhD
Professor
University of California, Los Angeles