Effects of an Activity Control System in Patients With Diabetes: a Randomized Controlled Trial

Study Overview
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Brief Summary
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Using a smart device (Beprevent) to monitor activities of daily living improves the lifestyle of patients with DM2

Detailed Description
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A 6-month randomized clinical trial to evaluate a home activity control system (Beprevent) in the management of the patient with DM2, through the individualized labeling of objects related to them. The study will include 20 patients with DM2 (10 in the intervention group and 10 in the control group) who live alone or with people who can´t move on their own. Data will be recorded to measure the degree of satisfaction of professionals and participants in the study, and clinical and epidemiological data at the start of the study (in its baseline situation) and at the end of the study (at 6 months), to assess the changes produced and Compare them between both study groups.

Official Title
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Effects of an Activity Control System in Patients With Diabetes: a Randomized

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Beprevent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years, with the ability to give informed consent Patient who has autonomy to carry out activities of daily living (Barthel = 100) patient diagnosed with Diabetes Mellitus patient in pharmacological treatment To live alone or with a person who cannot move on their own they do not plan to change their address in the 6 months after inclusion in the study Exclusion Criteria: • DM2 patients whose most recent HbA1c value is ≤7%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Beprevent<br>10 will become part of the intervention group. Each of the participants in the intervention group is selected. At first, they are given a series of questionnaires, later (1 day later) we stay at their home to install the Beprevent device, which will remain in their home for a period of two weeks, to finish and once the device of your home, we will proceed to pass the same questionnaires as at the beginning of the test, in order to compare results. | Other: Beprevent<br>* 10 will become part of the intervention group. At first, they are given a series of questionnaires, later (1 day later) we stay at their home to install the Beprevent device, which will remain in their home for a period of two weeks, to finish and once the device of your home, we will proceed to pass the same questionnaires as at the beginning of the test, in order to compare results.<br>|
| No Intervention: patients only evaluated<br>10 will be included in the control group. During the period of the study, we will pass the same questionnaires in the participants assigned to the control group, also leaving a time interval of two weeks, and no device will be installed, nor will any monitoring be carried out in their homes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Knowledge Questionnaire | The Diabetes Knowledge Questionnaire (DKQ-24) is a questionnaire made up of 24 questions about basic knowledge of the disease (10 items), glycemic control (7 items) and prevention of complications (7 items). The questions are closed, with answer options yes, no and I don't know. Its maximum score is 24. The patient has better knowledge about diabetes the higher the score. | 15 minuts | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial intelligence, diabetes mellitus, self-care, telemedicine