Type 2 Diabetes Mellitus
Conditions
Keywords
mHealth, Hispanic/Latinos, Diabetes Self-Management Education
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.
Interventions
BEHAVIORALYo Puedo + mHealth
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.
Sponsors
Universidad Iberoamericana
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1C From Baseline | Baseline, 3, 6 months | The change in A1C from baseline to 6 months is the result of the Generalized Linear Mixed Models (GLMM) with an intent-to-treat analysis that was used. HbA1c was measured from finger stick blood sample. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes Self-Efficacy From Baseline | 3 months | Self-efficacy will be measured by the Stanford Diabetes Self-Efficacy Scale, an 8-item scale specific to T2D self-management self-efficacy. |
| Dietary Intake | Baseline | Dietary intake will be evaluated by a two-day diet history |
| Change in Dietary Intake From Baseline | 3 months | Dietary intake will be evaluated by a two-day diet history |
| Physical Activity | Baseline | Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer. |
| Change in Physical Activity From Baseline | 3 months | Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer. |
| Diabetes Self-Efficacy | Baseline | Self-efficacy will be measured by the Stanford Diabetes Self-Efficacy Scale, an 8-item scale specific to T2D self-management self-efficacy. |
| Baseline Systolic and Diastolic Blood Pressure | Baseline | Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged |
| Change in Baseline Systolic and Diastolic Blood Pressure From Baseline | 3 months | Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged |
| Body Mass Index (BMI) | Baseline | A calibrated electronic scale will be used to record weight and a wall-based stadiometer will be used to record height. Weight and height will be combined to report BMI in kg/m\^2. |
| Change in Body Mass Index (BMI) From Baseline | 3 months | A calibrated electronic scale will be used to record weight and a wall-based stadiometer will be used to record height. Weight and height will be combined to report BMI in kg/m\^2. |
| Diabetes Self-management | Baseline | Measured by the Summary of Diabetes Self-Care Activities questionnaire, a multi-dimensional12-item scale with items on general diet, specific diet, monitoring blood glucose, foot care, and smoking |
| Change in Diabetes Self-management From Baseline | 3 months | Measured by the Summary of Diabetes Self-Care Activities questionnaire, a multi-dimensional12-item scale with items on general diet, specific diet, monitoring blood glucose, foot care, and smoking |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of Recruitment | through study completion, about 1 year | Rates of recruitment will be collected by researchers to evaluate feasibility. |
| Attrition | through study completion, about 1 year | This will be collected by researchers to evaluate feasibility. The number of participants who do not complete the study interventions and the reasons why will be recorded by study personnel. |
| Protocol Implementation | through study completion, about 1 year | This will be collected by researchers to evaluate feasibility. The CHWs will complete a Protocol Implementation Form after each session that documents attendance, length of the session, content of session, protocol implementation, and any deviation from protocol implementation |
| Fidelity of Yo Puedo Sessions | through study completion, about 1 year | This will be collected by researchers to evaluate feasibility. A study Co-Investigator will observe 10% of sessions to evaluate fidelity of Yo Puedo sessions. |
| Satisfaction With Program | 6 months | This measure will be used to evaluate the acceptability of the Yo Puedo program. Participants will be given a short survey and interview about their experience and satisfaction with the program. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Yo Puedo This group will receive the modified Yo Puedo + mHealth program.
Yo Puedo + mHealth: 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. | 26 |
| Wait-list Control This group will not receive the Yo Puedo + mHealth program during the 6 month data collection period, but will be invited to participate in it after data collection has finished. | 21 |
| Total | 47 |
Baseline characteristics
| Characteristic | Yo Puedo | Wait-list Control | Total |
|---|---|---|---|
| Age, Continuous | 53.9 years STANDARD_DEVIATION 9.2 | 56.8 years STANDARD_DEVIATION 8.3 | 55.4 years STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 21 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Marital Status | 15 Participants | 13 Participants | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 21 Participants | 47 Participants |
| Region of Enrollment Mexico | 26 participants | 21 participants | 47 participants |
| Sex: Female, Male Female | 17 Participants | 14 Participants | 31 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 21 |
| other Total, other adverse events | 8 / 26 | 2 / 21 |
| serious Total, serious adverse events | 0 / 26 | 1 / 21 |
Outcome results
Primary
Change in Hemoglobin A1C From Baseline
The change in A1C from baseline to 6 months is the result of the Generalized Linear Mixed Models (GLMM) with an intent-to-treat analysis that was used. HbA1c was measured from finger stick blood sample.
Time frame: Baseline, 3, 6 months
Population: Intention to treat analysis included all observations for all relevant time points used in the calculation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Yo Puedo | Change in Hemoglobin A1C From Baseline | Change from baseline | -1.76 percentage HbA1c | Standard Deviation 0.3 |
| Yo Puedo | Change in Hemoglobin A1C From Baseline | Baseline | 9.32 percentage HbA1c | Standard Deviation 1.44 |
| Yo Puedo | Change in Hemoglobin A1C From Baseline | 3 months | 7.85 percentage HbA1c | Standard Deviation 1.4 |
| Yo Puedo | Change in Hemoglobin A1C From Baseline | 6 months | 7.56 percentage HbA1c | Standard Deviation 1.5 |
| Wait-list Control | Change in Hemoglobin A1C From Baseline | 6 months | 8.05 percentage HbA1c | Standard Deviation 1.51 |
| Wait-list Control | Change in Hemoglobin A1C From Baseline | Change from baseline | -0.97 percentage HbA1c | Standard Deviation 0.33 |
| Wait-list Control | Change in Hemoglobin A1C From Baseline | 3 months | 8.76 percentage HbA1c | Standard Deviation 1.4 |
| Wait-list Control | Change in Hemoglobin A1C From Baseline | Baseline | 9.09 percentage HbA1c | Standard Deviation 1.58 |
p-value: <0.15Mixed Models Analysis
Secondary
Baseline Systolic and Diastolic Blood Pressure
Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged
Time frame: Baseline
Secondary
Body Mass Index (BMI)
A calibrated electronic scale will be used to record weight and a wall-based stadiometer will be used to record height. Weight and height will be combined to report BMI in kg/m\^2.
Time frame: Baseline
Secondary
Change in Baseline Systolic and Diastolic Blood Pressure From Baseline
Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged
Time frame: 6 months
Secondary
Change in Baseline Systolic and Diastolic Blood Pressure From Baseline
Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged
Time frame: 3 months
Secondary
Change in Body Mass Index (BMI) From Baseline
A calibrated electronic scale will be used to record weight and a wall-based stadiometer will be used to record height. Weight and height will be combined to report BMI in kg/m\^2.
Time frame: 3 months
Secondary
Change in Body Mass Index (BMI) From Baseline
A calibrated electronic scale will be used to record weight and a wall-based stadiometer will be used to record height. Weight and height will be combined to report BMI in kg/m\^2.
Time frame: 6 months
Secondary
Change in Diabetes Self-Efficacy From Baseline
Self-efficacy will be measured by the Stanford Diabetes Self-Efficacy Scale, an 8-item scale specific to T2D self-management self-efficacy.
Time frame: 6 months
Secondary
Change in Diabetes Self-Efficacy From Baseline
Self-efficacy will be measured by the Stanford Diabetes Self-Efficacy Scale, an 8-item scale specific to T2D self-management self-efficacy.
Time frame: 3 months
Secondary
Change in Diabetes Self-management From Baseline
Measured by the Summary of Diabetes Self-Care Activities questionnaire, a multi-dimensional12-item scale with items on general diet, specific diet, monitoring blood glucose, foot care, and smoking
Time frame: 6 months
Secondary
Change in Diabetes Self-management From Baseline
Measured by the Summary of Diabetes Self-Care Activities questionnaire, a multi-dimensional12-item scale with items on general diet, specific diet, monitoring blood glucose, foot care, and smoking
Time frame: 3 months
Secondary
Change in Dietary Intake From Baseline
Dietary intake will be evaluated by a two-day diet history
Time frame: 3 months
Secondary
Change in Dietary Intake From Baseline
Dietary intake will be evaluated by a two-day diet history
Time frame: 6 months
Secondary
Change in Physical Activity From Baseline
Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer.
Time frame: 3 months
Secondary
Change in Physical Activity From Baseline
Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer.
Time frame: 6 months
Secondary
Diabetes Self-Efficacy
Self-efficacy will be measured by the Stanford Diabetes Self-Efficacy Scale, an 8-item scale specific to T2D self-management self-efficacy.
Time frame: Baseline
Secondary
Diabetes Self-management
Measured by the Summary of Diabetes Self-Care Activities questionnaire, a multi-dimensional12-item scale with items on general diet, specific diet, monitoring blood glucose, foot care, and smoking
Time frame: Baseline
Secondary
Dietary Intake
Dietary intake will be evaluated by a two-day diet history
Time frame: Baseline
Secondary
Physical Activity
Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer.
Time frame: Baseline
Other Pre-specified
Attrition
This will be collected by researchers to evaluate feasibility. The number of participants who do not complete the study interventions and the reasons why will be recorded by study personnel.
Time frame: through study completion, about 1 year
Other Pre-specified
Fidelity of Yo Puedo Sessions
This will be collected by researchers to evaluate feasibility. A study Co-Investigator will observe 10% of sessions to evaluate fidelity of Yo Puedo sessions.
Time frame: through study completion, about 1 year
Other Pre-specified
Protocol Implementation
This will be collected by researchers to evaluate feasibility. The CHWs will complete a Protocol Implementation Form after each session that documents attendance, length of the session, content of session, protocol implementation, and any deviation from protocol implementation
Time frame: through study completion, about 1 year
Other Pre-specified
Rate of Recruitment
Rates of recruitment will be collected by researchers to evaluate feasibility.
Time frame: through study completion, about 1 year
Other Pre-specified
Satisfaction With Program
This measure will be used to evaluate the acceptability of the Yo Puedo program. Participants will be given a short survey and interview about their experience and satisfaction with the program.
Time frame: 6 months