Clinical trial NCT03159299: Yo Puedo! Diabetes Self-Management Education + mHealth in Mexico City
Official title: Yo Puedo! Diabetes Self-Management Education + mHealth in Mexico City
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: mHealth
Hispanic/Latinos
Diabetes Self-Management Education
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Universidad Iberoamericana
First posted: 2017-05-18
Enrollment: 47
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

Phase 1:

* For provider interviews/focus groups: administrator or health care provider at Seguro Popular clinic with at least 3 months experience.
* For adult interviews/focus groups: 21-65 years of age and have had T2D for at least one year

Phase 2:

* Age 21-65 years; receiving care for T2D at a Seguro Popular clinic; diagnosed with T2D with A1C \>8.0% and duration ≤ 5 years; medically stable and safe to exercise; and have a cell phone (MMS text-messaging will be provided).

Exclusion Criteria:

Phase 2:

* Cognitive impairment, severe untreated clinical depression in the past 6 months, major cardiac event in past 12 months, uncontrolled blood pressure, resting tachycardia, renal failure, severe peripheral neuropathy, treatment of T2D with insulin, and participation in focus groups or interviews.

Primary outcomes:
measure: Change in Hemoglobin A1C From Baseline
timeFrame: Baseline, 3, 6 months
Secondary outcomes:
measure: Baseline Systolic and Diastolic Blood Pressure
timeFrame: Baseline
measure: Change in Baseline Systolic and Diastolic Blood Pressure From Baseline
timeFrame: 3 months
measure: Change in Baseline Systolic and Diastolic Blood Pressure From Baseline
timeFrame: 6 months
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Change in Body Mass Index (BMI) From Baseline
timeFrame: 3 months
measure: Change in Body Mass Index (BMI) From Baseline
timeFrame: 6 months
measure: Diabetes Self-management
timeFrame: Baseline
measure: Change in Diabetes Self-management From Baseline
timeFrame: 3 months
measure: Change in Diabetes Self-management From Baseline
timeFrame: 6 months
measure: Dietary Intake
timeFrame: Baseline
measure: Change in Dietary Intake From Baseline
timeFrame: 3 months
measure: Change in Dietary Intake From Baseline
timeFrame: 6 months
measure: Physical Activity
timeFrame: Baseline
measure: Change in Physical Activity From Baseline
timeFrame: 3 months
measure: Change in Physical Activity From Baseline
timeFrame: 6 months
measure: Diabetes Self-Efficacy
timeFrame: Baseline
measure: Change in Diabetes Self-Efficacy From Baseline
timeFrame: 3 months
measure: Change in Diabetes Self-Efficacy From Baseline
timeFrame: 6 months
Other outcomes:
measure: Satisfaction With Program
timeFrame: 6 months
measure: Rate of Recruitment
timeFrame: through study completion, about 1 year
measure: Attrition
timeFrame: through study completion, about 1 year
measure: Protocol Implementation
timeFrame: through study completion, about 1 year
measure: Fidelity of Yo Puedo Sessions
timeFrame: through study completion, about 1 year
Locations:
city: Orange
country: United States
facility: Yale School of Nursing
state: Connecticut
Study officials:
affiliation: Yale University
name: Robin Whittemore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Whittemore R, Vilar-Compte M, De La Cerda S, Delvy R, Jeon S, Burrola-Mendez S, Pardo-Carrillo M, Lozano-Marrufo A, Perez-Escamilla R. inverted exclamation markSi, Yo Puedo Vivir Sano con Diabetes! A Self-Management Randomized Controlled Pilot Trial for Low-Income Adults with Type 2 Diabetes in Mexico City. Curr Dev Nutr. 2020 Apr 14;4(5):nzaa074. doi: 10.1093/cdn/nzaa074. eCollection 2020 May.