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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Beprevent
Sponsored by
Maimónides Biomedical Research Institute of Córdoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring artificial intelligence, diabetes mellitus, self-care, telemedicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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%

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Beprevent

    patients only evaluated

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 4, 2020
    Last Updated
    December 22, 2020
    Sponsor
    Maimónides Biomedical Research Institute of Córdoba
    Collaborators
    Universidad Católica San Antonio de Murcia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04380844
    Brief Title
    Effects of an Activity Control System in Patients With Diabetes: a Randomized Controlled Trial
    Official Title
    Effects of an Activity Control System in Patients With Diabetes: a Randomized
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2021 (Anticipated)
    Primary Completion Date
    May 1, 2021 (Anticipated)
    Study Completion Date
    November 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Maimónides Biomedical Research Institute of Córdoba
    Collaborators
    Universidad Católica San Antonio de Murcia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2
    Keywords
    artificial intelligence, diabetes mellitus, self-care, telemedicine

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Beprevent
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    patients only evaluated
    Arm Type
    No Intervention
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    Beprevent
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Diabetes Knowledge Questionnaire
    Description
    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.
    Time Frame
    15 minuts

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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%
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Antonio Luque
    Phone
    0034671596070
    Email
    uicec@imibic.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    PEDRO MONTAGUT MARTINEZ, nurse
    Phone
    + (34) 630258878
    Email
    pedromontagut@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jesús Gómez Lama, MD
    Organizational Affiliation
    Maimónides Biomedical Research Institute of Córdoba
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    David Pérez Cruzado
    Organizational Affiliation
    Universidad Católica San Antonio de Murcia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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