Development of an Information Board and Mobile Application for the Care of Type 2 Diabetes at the First Level of Medical Care for the Health Sector in Mexico
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,512
- Locations
- 6
- Primary Endpoint
- HbA1C
Study Overview
Brief Summary
The SANENT trial is a primary care-based, prospective, two-arm, randomized controlled, open-label, blinded-endpoint study with the aim to compare a diabetes management strategy using an information board and a mobile application versus standard care in patients with uncontrolled type 2 diabetes. This trial aims to recruit 1440 type 2 diabetes patients during a period of six months until the requested number of participants have been achieved. The total length of the intervention will be one year. The SANENT trial protocol is presented according to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) recommendations
Detailed Description
Trial setting
This trial will be conducted within primary health care practices in three states (Colima, Tlaxcala y Guanajuato) of Mexico. These states were selected because they have a high prevalence of diabetes and have implemented an Electronic Health Record System.
Patient and Public involvement
During the planning phase of the study, a pilot project was carried out evaluating the design and applicability of the information board and mobile application in 31 type 2 diabetes patients. The final intervention was then modified according to the qualitative data received from the patients. the investigators also involved primary healthcare clinicians in the development and evaluation of the information. The results of the study will be made available to all trial participants and participating general practices. Finally, the General Health Council of Mexico who manages the countries public health system is included as collaboration partner in this trial and has been involved in all phases of the design of this study.
Sample size calculations
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women treated for type 2 diabetes with an HbA1C>8.5%;
- •≥20 years-of-age;
- •Signed up for diabetes treatment and control in one of the participating primary healthcare practices.
- •Having access to a mobile phone (or having a family member who will help them in sending, understanding, and retrieving messages and information provided in Spanish language through the mobile application)
Exclusion Criteria
- •Participants who are pregnant, within 3 months postpartum or planning pregnancy during the trial;
- •Breastfeeding;
- •Serious medical condition (i.e. dialysis treatment);
- •Having been admitted to hospital within the last 3 months for hyperglycemia or hypoglycemia;
- •Not permanent residents of the states where the study is conducted.
Outcomes
Primary Outcomes
HbA1C
Time Frame: 12 months
Change in HbA1C
Secondary Outcomes
- Changes in albumin to creatine ratio(12 months)
- Quality of life changes(12 months)
- Blood lipids changes(12 months)
- Blood pressure changes(12 months)
- Treatment compliance change(12 months)
- Mental health improvement(12 months)
- Physical activity changes(12 months)
- Body mass index(12 months)
- Waist circumference(12 months)