Yo Puedo! Diabetes Self-Management Education + mHealth in Mexico City
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aims of this study are:

        1. To translate an evidence-based diabetes self-management education (DSME) program, Yo
           Puedo!, to the cultural norms, expertise of providers, and systems of care in Seguro
           Popular clinics in Mexico. The program will be adapted through a collaborative team of
           diabetes experts in the US and Mexico, Seguro Popular clinic administrators, physicians,
           nurses and adults with type 2 diabetes (T2D) in Mexico City, Mexico. This will include
           development and testing of a theory-based mHealth (pictorial text-messaging) component.

        2. To evaluate the feasibility (process of implementation, fidelity of sessions,
           attendance, attrition), acceptability (interviews with nurse, CHW, participants) and
           preliminary efficacy of Yo Puedo!+mHealth in adults with T2D in Mexico City. A
           randomized, controlled pilot study design will be used in which 40 adults with T2D are
           randomized to the Yo Puedo! + mHealth or a wait-list control condition with the
           hypothesis that clinical [A1C, body mass index (BMI), blood pressure (BP)], T2D
           self-management, and self-efficacy outcomes will be greater in You Puedo!+mHealth
           participants compared to the wait-list control condition at 3 and 6 month follow-up. A
           secondary hypothesis that the Yo Puedo! + mHealth program is feasible and acceptable to
           adults with T2D and providers and that fidelity of the program will be maintained.
    

Detailed description: 
      This mixed-method design study will be accomplished in two phases with an interdisciplinary,
      bi-national collaboration between the Yale School of Nursing, the Yale School of Public
      Health, the Iberoamericana University in Mexico City, and up to 10 Seguro Popular clinics to
      evaluate the adapted DSME program for adults with T2D in Mexico City.

      Phase 1: While the Yo Puedo! program addresses some of the needs of Mexican adults with type
      2 diabetes - interactive health education for low health literacy, Spanish language materials
      and video novellas, and activities to enhance self-efficacy, the program was developed to
      address the needs of Latino immigrants in the U.S, who are from different Latin countries.
      The program needs to be adapted to Mexican adults with respect to personal beliefs about
      disease causation, cultural health practices, self-care practices of type 2 diabetes, and
      issues regarding access to care. This aim will be accomplished by using an interpretive and
      participatory method with a collaborative team of diabetes experts in the US and Mexico,
      Seguro Popular clinic administrators, physicians, and nurses, and adults with T2D in Mexico
      City, Mexico. In focus groups and interviews, the study team will explore how the cultural
      context, family, and health system shape beliefs and practices related to T2D. Access and
      familiarity with texting technology to identify potential barriers to using a text-messaging
      mHealth program will also be explored. These results will inform any modifications to the Yo
      Puedo! curriculum that may need to be made before Phase 2 can begin.

      Phase 2: A randomized, controlled pilot study design will be used in which 40 adults with T2D
      are randomized to the Yo Puedo + mHealth or wait-list control condition with the hypothesis
      that clinical (A1C, BMI, BP), T2D self-management, and self-efficacy outcomes will be greater
      in Yo Puedo + mHealth participants compared to the wait-list control condition at 3 and 6
      month follow-up. It is also hypothesized that the Yo Puedo + mHealth program is feasible and
      acceptable to adults with T2D and providers, and that fidelity of the program will be
      maintained. Those in the control group will be invited to participate in the program after
      completion of the 6-month data collection. Interviews will be conducted with the nurse,
      community health worker (CHW), participants, and select clinic personnel to identify
      barriers, facilitators, and acceptability of the program from multiple perspectives,
      recognizing the complexity of the health care system. Detailed notes on the process of
      implementation will be carefully recorded with the purpose of identifying successful and
      unsuccessful components of the program (positive and negative feedback loops in a complex
      system).

      Setting. The study will be conducted in up to 10 Seguro Popular clinics. These clinics are
      part of the Social Protection System in Health in Mexico. Individuals who obtain health care
      at these clinics are covered by public health insurance (Seguro Popular), and the services
      offered for T2D care include medical visits, referrals to specialists and nutritionist when
      needed, laboratory testing, and free medicines. The medical visits include medication
      prescription, blood pressure management, lipid monitoring, and eye/foot care. Laboratory
      analyses vary from patient to patient but generally includes 3 annual tests of A1C, although
      other glucose, urine, and lipids tests are also available. Patients with complications are
      referred to specialized health centers. Evidence suggests that the impact of the Seguro
      Popular in adults with T2D has been positive.

      Interventions. All participants will receive standard T2D care at a Seguro Popular clinic as
      described above. The wait-list control condition group will receive a handout on T2D
      self-management and the opportunity to participate in the Yo Puedo! + mHealth program at the
      completion of 6-month data collection. The Yo Puedo! + mHealth DSME program includes: a) an
      initial consultation with the nurse to collaboratively determine goals; b) five interactive
      group-based sessions led by the CHW on T2D self-management that is culturally relevant and at
      a low health literacy level (Yo Puedo! protocol adapted for Mexican context; c) behavioral
      support to collaboratively problem-solve barriers to change; and d) empowerment-based
      strategies to facilitate provider-patient communication. The Yo Puedo! program will be
      supplemented by 2-way text-messaging capability provided by a web-based platform with privacy
      and security rules, which allows for automated and personalized messages and a database to
      store all messages. Automated daily text messages will include messages to promote
      understanding of T2D self-management, self-efficacy, and adherence to self-management goals.
      The in-person component will be 6 weeks; daily text messaging will be for 6 months.
    

Intervention name(s): Yo Puedo + mHealth
Intervention type(s): Behavioral
Intervention description(s): This intervention is an adapted diabetes self-management education program. Study participants will attend group classes weekly for 6 weeks, and receive daily text messages over 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: mHealth; Hispanic/Latinos; Diabetes Self-Management Education