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

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

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

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Beprevent

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Beprevent; 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.
No Intervention: patients only evaluated; 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?

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

Collaborators and Investigators

• Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Collaborators: Universidad Católica San Antonio de Murcia
• Investigators: Principal Investigator: Jesús Gómez Lama, MD, Maimónides Biomedical Research Institute of Córdoba; Principal Investigator: David Pérez Cruzado, Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: April 4, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: telemedicine; artificial intelligence; diabetes mellitus; self-care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: orcid.org/0000-0002-869

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No