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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04380844
• Other study ID #: orcid.org/0000-0002-869
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: December 2020
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: Antonio Luque
• Phone: 0034671596070
• Email: uicec[@]imibic.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba	Universidad Católica San Antonio de Murcia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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