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Mobile Health Application for Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
capABILITY
Sponsored by
University of South Alabama
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Must be at least 21 years of age or older
  • Current diagnosis of type II diabetes
  • Must have access to a smartphone and daily internet (WiFi)

Exclusion Criteria:

  • Anyone with gestational diabetes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Other

    Other

    Arm Label

    Control

    Facilitator Message Group

    Spark Trigger Group

    Arm Description

    This was the control group for the messaging component of the study (push notifications). These participants only received the mobile health application called capABILITY without messages.

    This group of participants received the mobile health application called capABILITY and received three facilitator messages per week. Facilitator messages are designed to help people who lack ability to do something.

    This group of participants received the mobile health application called capABILITY and received three spark messages per week. Spark messages are designed to help people who lack ability to do something.

    Outcomes

    Primary Outcome Measures

    20 participants baseline self-efficacy score will be measured at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
    Participants completed the Perceived Diabetes Self-Management Scale at baseline and post intervention to measure their self-efficacy. The measure (scale) consists of eight questions ranging from strongly disagree (1) to strongly agree (5). All items are scored so that high scores equals higher perceived self-efficacy.
    20 participants baseline diabetes knowledge score will be measure at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
    Participants completed the Brief Diabetes Knowledge Test (DKT2) at baseline and post intervention to measure their overall type II diabetes knowledge. The measure (scale) consists of twenty- three multiple choice knowledge questions. The score was calculated based on the number of questions answered correctly with higher scores representing a higher knowledge level.
    20 participants baseline diabetes self-management score will be measured at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
    Participants completed the Summary of Diabetes Self-Care Activities Questionnaire at baseline and post intervention to measure their diabetes self-care. The measure (scale) consists of twenty five questions ranging from a score of 1 (days per week) to 7 (days per week). All items are scored so that high scores equals higher self-care.

    Secondary Outcome Measures

    Participants will login and use capABILITY quicker (time measured in seconds) after receiving a behavioral trigger message than those participants who don't receive a behavioral trigger.
    Participants will engage quicker with capABILITY after they receive behavioral triggers (Sparks and Facilitators) than those participants who don't receive behavioral triggers. Participants in the Spark and Facilitator groups received push messages (triggers) on Tuesday, Thursday and Saturday at 10:00 am. Time was measured in seconds and the calculation was the time between push notification delivery (10:00am) and the participant login to capABILITY. The smaller the number in seconds the quicker the login time from push notification delivery.
    Participants who receive a Spark trigger message will login and use capABILITY quicker (time measured in seconds) than those participants who receive Facilitator trigger message.
    Participants will engage quicker with capABILITY after they receive Spark trigger messages than those who receive a Facilitator trigger message. Participants in the Spark and Facilitator groups received push messages (triggers) on Tuesday, Thursday and Saturday at 10:00 am. Time was measured in seconds and the calculation was the time between push notification delivery (10:00am) and the participant login to capABILITY. The smaller the number in seconds the quicker the login time from push notification delivery.

    Full Information

    First Posted
    October 8, 2019
    Last Updated
    October 17, 2019
    Sponsor
    University of South Alabama
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04132089
    Brief Title
    Mobile Health Application for Diabetes
    Official Title
    Incorporating Behavioral Trigger Measures Into a Mobile Health (mHealth) App Design for Chronic Disease Management: Pilot Study in Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    January 1, 2017 (Actual)
    Study Completion Date
    April 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of South Alabama

    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
    Creation of a mobile health application for individuals with type II diabetes. This application was designed to improve knowledge, self-efficacy and self-care. The application delivered educational material and provided push notifications (messages). It also allowed for the participants to key in blood glucose levels, carbohydrate consumption and daily exercise.
    Detailed Description
    capABILITY (the mobile health application) was designed to cover three main diabetes content areas which the investigators call modules: diet (module 1), exercise (module 2) and self-management (module 3) (i.e. medication adherence, glucose monitoring). The length of the study was 9 weeks in duration with three weeks of content per module. Within each module new material was delivered each week through capABILITY. Essentially, every Monday started a new week's worth of educational material that was intended to last until Sunday. Each participant was randomly assigned to either the control group (no triggers), spark trigger group or facilitator trigger group. At the beginning of each module the participants would be randomly assigned to one of the three aforementioned classification groups (this was a 2-Factor Cross-Over Design). The investigators utilized the Perceived Diabetes Self-Efficacy Scale , Diabetes Knowledge Test developed by Michigan University, and the Summary of Diabetes Self-Care Activities Measures scale (SDSCA) . All the participants completed the perceived diabetes self-efficacy scale along with the knowledge test and SDSCA Pre/Post intervention. In addition, the participants answered one self-efficacy, knowledge, self-care and goal question at the conclusion of each week within capABILITY.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    A three factor cross-over design was utilized.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    This was the control group for the messaging component of the study (push notifications). These participants only received the mobile health application called capABILITY without messages.
    Arm Title
    Facilitator Message Group
    Arm Type
    Other
    Arm Description
    This group of participants received the mobile health application called capABILITY and received three facilitator messages per week. Facilitator messages are designed to help people who lack ability to do something.
    Arm Title
    Spark Trigger Group
    Arm Type
    Other
    Arm Description
    This group of participants received the mobile health application called capABILITY and received three spark messages per week. Spark messages are designed to help people who lack ability to do something.
    Intervention Type
    Behavioral
    Intervention Name(s)
    capABILITY
    Intervention Description
    All participants utilized the designed capABILITy application. The application consisted of education material and persuasive messaging. There were two types of messaging components named facilitators and sparks. This created three groups consisting of: control, facilitators and sparks. Participants spent 1 month in each group (total duration of the study was three months).
    Primary Outcome Measure Information:
    Title
    20 participants baseline self-efficacy score will be measured at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
    Description
    Participants completed the Perceived Diabetes Self-Management Scale at baseline and post intervention to measure their self-efficacy. The measure (scale) consists of eight questions ranging from strongly disagree (1) to strongly agree (5). All items are scored so that high scores equals higher perceived self-efficacy.
    Time Frame
    9 Weeks
    Title
    20 participants baseline diabetes knowledge score will be measure at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
    Description
    Participants completed the Brief Diabetes Knowledge Test (DKT2) at baseline and post intervention to measure their overall type II diabetes knowledge. The measure (scale) consists of twenty- three multiple choice knowledge questions. The score was calculated based on the number of questions answered correctly with higher scores representing a higher knowledge level.
    Time Frame
    9 Weeks
    Title
    20 participants baseline diabetes self-management score will be measured at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
    Description
    Participants completed the Summary of Diabetes Self-Care Activities Questionnaire at baseline and post intervention to measure their diabetes self-care. The measure (scale) consists of twenty five questions ranging from a score of 1 (days per week) to 7 (days per week). All items are scored so that high scores equals higher self-care.
    Time Frame
    9 Weeks
    Secondary Outcome Measure Information:
    Title
    Participants will login and use capABILITY quicker (time measured in seconds) after receiving a behavioral trigger message than those participants who don't receive a behavioral trigger.
    Description
    Participants will engage quicker with capABILITY after they receive behavioral triggers (Sparks and Facilitators) than those participants who don't receive behavioral triggers. Participants in the Spark and Facilitator groups received push messages (triggers) on Tuesday, Thursday and Saturday at 10:00 am. Time was measured in seconds and the calculation was the time between push notification delivery (10:00am) and the participant login to capABILITY. The smaller the number in seconds the quicker the login time from push notification delivery.
    Time Frame
    9 Weeks
    Title
    Participants who receive a Spark trigger message will login and use capABILITY quicker (time measured in seconds) than those participants who receive Facilitator trigger message.
    Description
    Participants will engage quicker with capABILITY after they receive Spark trigger messages than those who receive a Facilitator trigger message. Participants in the Spark and Facilitator groups received push messages (triggers) on Tuesday, Thursday and Saturday at 10:00 am. Time was measured in seconds and the calculation was the time between push notification delivery (10:00am) and the participant login to capABILITY. The smaller the number in seconds the quicker the login time from push notification delivery.
    Time Frame
    9 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Must be at least 21 years of age or older Current diagnosis of type II diabetes Must have access to a smartphone and daily internet (WiFi) Exclusion Criteria: Anyone with gestational diabetes
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Scott Sittig, PhD
    Organizational Affiliation
    University of South Alabama
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The participant data from this study will not be shared with other researchers. Findings of the study will be published however.
    Citations:
    PubMed Identifier
    32175908
    Citation
    Sittig S, Wang J, Iyengar S, Myneni S, Franklin A. Incorporating Behavioral Trigger Messages Into a Mobile Health App for Chronic Disease Management: Randomized Clinical Feasibility Trial in Diabetes. JMIR Mhealth Uhealth. 2020 Mar 16;8(3):e15927. doi: 10.2196/15927.
    Results Reference
    derived

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    Mobile Health Application for Diabetes

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