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

Not Applicable

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Beprevent

• Registration Number: NCT04380844
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-04-04
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-08
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2020-12-24
• Study Start: 2021-02-01
• Primary Completion: 2021-05-01
• Study Completion: 2021-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beprevent	Beprevent	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.

Primary Outcome Measures

Name	Time	Method
Diabetes Knowledge Questionnaire	15 minuts	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.