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

Maimónides Biomedical Research Institute of Córdoba

Status: Unknown

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Beprevent

Study type: Interventional

Funder types: Other

Identifiers

NCT04380844

orcid.org/0000-0002-869

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Beprevent

Active Comparator group

Description:

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.

Treatment:

Other: Beprevent

patients only evaluated

No Intervention group

Description:

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.