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| Name | Class |
|---|---|
| Universidad Iberoamericana | OTHER |
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The aims of this study are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yo Puedo | Experimental | This group will receive the modified Yo Puedo + mHealth program. |
|
| Wait-list Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yo Puedo + mHealth | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| Change in Baseline Systolic and Diastolic Blood Pressure From Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Rate of Recruitment |
Inclusion Criteria:
Phase 1:
Phase 2:
Exclusion Criteria:
Phase 2:
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| Name | Affiliation | Role |
|---|---|---|
| Robin Whittemore, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Nursing | Orange | Connecticut | 06477 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32368713 | Derived | 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. |
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April 2020 - December 2020
Contact the Principal Investigator
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention to treat analysis included all observations for all relevant time points used in the calculation. | Posted | Mean | Standard Deviation | percentage HbA1c | Baseline, 3, 6 months |
|
Approximately one year
Data were collected on episodes of hypoglycemia or hyperglycemia at data collection times (3 and 6 months). There were 10 minor adverse events of hyperglycemia or hypoglycemia possibly or unrelated to study. There was one major adverse event of hypoglycemia requiring emergency room treatment of participant in the control group, unlikely related to the study. All treatment-related and non-treatment related adverse events are being reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | hypoglycemia | Systematic Assessment | Severe hypoglycemia requiring emergency room treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemic | Endocrine disorders | hypoglycemia | Systematic Assessment | Minor hypoglycemia resolved without medical intervention other than food for hypoglycemia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin Whittemore, PhD | Yale School of Nursing | 203-737-2351 | robin.whittemore@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2018 | Mar 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged |
| 3 months |
| 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 | 6 months |
| 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. | Baseline |
| 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. | 3 months |
| 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. | 6 months |
| 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 | Baseline |
| 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 | 3 months |
| 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 | 6 months |
| Dietary Intake | Dietary intake will be evaluated by a two-day diet history | Baseline |
| Change in Dietary Intake From Baseline | Dietary intake will be evaluated by a two-day diet history | 3 months |
| Change in Dietary Intake From Baseline | Dietary intake will be evaluated by a two-day diet history | 6 months |
| Physical Activity | Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer. | Baseline |
| Change in Physical Activity From Baseline | Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer. | 3 months |
| Change in Physical Activity From Baseline | Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer. | 6 months |
| 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. | Baseline |
| 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. | 3 months |
| 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. | 6 months |
Rates of recruitment will be collected by researchers to evaluate feasibility.
| through study completion, about 1 year |
| 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. | through study completion, about 1 year |
| 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 | through study completion, about 1 year |
| 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. | through study completion, about 1 year |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Marital Status | Count of Participants | Participants |
|
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. |
|
|
|
| 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 | Not Posted | Baseline | Participants |
| 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 | Not Posted | 3 months | Participants |
| 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 | Not Posted | 6 months | Participants |
| 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. | Not Posted | Baseline | Participants |
| 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. | Not Posted | 3 months | Participants |
| 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. | Not Posted | 6 months | Participants |
| 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 | Not Posted | Baseline | Participants |
| 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 | Not Posted | 3 months | Participants |
| 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 | Not Posted | 6 months | Participants |
| Secondary | Dietary Intake | Dietary intake will be evaluated by a two-day diet history | Not Posted | Baseline | Participants |
| Secondary | Change in Dietary Intake From Baseline | Dietary intake will be evaluated by a two-day diet history | Not Posted | 3 months | Participants |
| Secondary | Change in Dietary Intake From Baseline | Dietary intake will be evaluated by a two-day diet history | Not Posted | 6 months | Participants |
| Secondary | Physical Activity | Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer. | Not Posted | Baseline | Participants |
| Secondary | Change in Physical Activity From Baseline | Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer. | Not Posted | 3 months | Participants |
| Secondary | Change in Physical Activity From Baseline | Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer. | Not Posted | 6 months | Participants |
| 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. | Not Posted | Baseline | Participants |
| 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. | Not Posted | 3 months | Participants |
| 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. | Not Posted | 6 months | Participants |
| 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | Rate of Recruitment | Rates of recruitment will be collected by researchers to evaluate feasibility. | Not Posted | through study completion, about 1 year | Participants |
| 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. | Not Posted | through study completion, about 1 year | Participants |
| 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 | Not Posted | through study completion, about 1 year | Participants |
| 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. | Not Posted | through study completion, about 1 year | Participants |
| 0 |
| 26 |
| 0 |
| 26 |
| 8 |
| 26 |
| EG001 | 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. | 0 | 21 | 1 | 21 | 2 | 21 |
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| hyperglycemia | Endocrine disorders | hyperglycemia | Systematic Assessment | Minor hyperglycemia resolved without treatment |
|
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| D004700 | Endocrine System Diseases |