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The effect of an App for cell phones and tablets on the blood glucose of elderly people with Type 2 Diabetes

Effectiveness of a mobile device Application on glycated hemoglobin in elderly people with Type 2 Diabetes Mellitus: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8ywgvm8
Enrollment
Unknown
Registered
2022-11-21
Start date
2023-03-06
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

A single-blind randomized-controlled clinical trial will be carried out to evaluate the impact of an application for mobile devices and an educational booklet, validated by experts, on the process of
I02.233.332

Sponsors

Universidade de Brasília - Faculdade de Ceilândia
Lead Sponsor
Secretaria de Estado de Saúde do Distrito Federal
Collaborator

Eligibility

Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: Elderly aged between 60 and 75 years of both sexes; literate; access to electronic mobile devices; Internet access; medical diagnosis of type 2 diabetes for at least one year; use of oral medication for type 2 diabetes; able to have independence and autonomy to perform activities of daily living that will be measured by the Barthel index; in need of adaptation or supervision by third parties to carry out activities of daily living; who do not practice physical activity or who have insufficient physical activity, assessed using the International Physical Activity Questionnaire (IPAQ) short version

Exclusion criteria

Exclusion criteria: Elderly people using insulin; with multiple chronic comorbidities such as cancer, rheumatoid arthritis, congestive heart failure, severe depression, emphysema, Parkinson's disease, myocardial infarction, stroke, class III chronic renal failure or worse, end-stage disease such as metastatic cancer, class 4- 5, chronic lung disease requiring oxygen therapy, dialysis patients, severe functional and cognitive impairment; participants in another clinical trial, research study, or exercise program in which they perform similar balance and strength activities; have mobility limitations or use walking devices; diagnosis of progressive neurological disease or other acute or unstable medical condition that prevents exercise; cardiac risk classification II, III and IV according to the New York Heart Association (NYHA) Functional Classification

Design outcomes

Primary

MeasureTime frame
It is expected that the intervention group, after using the intervention for 3 months (application for mobile devices), will have a 1.0% reduction in glycated hemoglobin (HbA1c). The HbA1c will be checked by means of a blood test in the pre (up to 30 days before the intervention) and in the post-intervention (up to 30 days after the intervention).

Secondary

MeasureTime frame
It is expected that, after the intervention with the application for mobile devices for 3 months, at least 80% of the elderly in the intervention group will have a score equal to or greater than 8 points on the Diabetes Knowledge Scale (DKN-A). A score greater than 8 points indicates sufficient knowledge about diabates. The DKN-A scale will be applied pre (up to 30 days before the intervention) and post-test (up to 30 days after the intervention).;It is expected that, after the intervention with the application for mobile devices for 3 months, at least 80% of the elderly in the intervention group have a score equal to or greater than 5 points in each of the dimensions of self-care evaluated through the Questionnaire of Self-Care Activities with Diabetes – QAD. The QAD has six dimensions and 15 items for assessing self-care with diabetes and, in addition, it has three other items for the assessment of smoking. The answers range from 0 to 7, with zero being the least desirable condition and 7 the most favorable situation. The QAD questionnaire will be applied pre (up to 30 days before the intervention) and post-test (up to 30 days after the intervention).;It is expected that, after the intervention with the application for mobile devices for 3 months, at least 80% of the elderly in the intervention group will have an average score between 3.8 and 5.0 in the self-efficacy assessment instrument, which will be evaluated through the Self-Efficacy Scale in Diabetes – Short Version EAD-VC. The participant will answer the eight questions using a 5-point Likert Scale: “I very much agree” – 5 points; “I agree” – 4 points; “I have no opinion” – 3 points; “I do not agree” – 2 points, and “I do not agree at all” – 1 point. The final score of the instrument is calculated using the average of the scores in the eight questions, and the score is considered high from 3.8 to 5.0, moderate from 2.4 to 3.7 and low from 1 to 2.3.

Countries

Brazil

Contacts

Public ContactSilvana Funghetto

Universidade de Brasília - Faculdade de Ceilândia

silvanasf@unb.br+55(61)3107-8937

Outcome results

None listed

Source: REBEC (via WHO ICTRP)