Building Capacity in Human-Centered Design: Developing a Diabetes Mobile Health Application for and With Kenyan Adolescents
Primary Purpose
Type 1 Diabetes
Status
Active
Phase
Phase 1
Locations
Kenya
Study Type
Interventional
Intervention
Diary/Journal
Sponsored by
About this trial
This is an interventional device feasibility trial for Type 1 Diabetes focused on measuring Human-Centered Design, Mobile Phones, Diabetes
Eligibility Criteria
Inclusion Criteria:
- T1D diagnosis 13-18 years old
- Have an A1c > 7
- Uses a phone
- Fluent in Swahili
Exclusion Criteria:
- Being treated for significant medical condition other than T1D
- Being treated for eating disorder
Sites / Locations
- Nairobi
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Youth Engage with Diary
Arm Description
24 youth will use the Diary for one month
Outcomes
Primary Outcome Measures
Building Capacity in Human-Centered Design: Developing a Diabetes mHealth Application for and with Kenyan Adolescents
Feasibility of Diary
Secondary Outcome Measures
Full Information
NCT ID
NCT05560256
First Posted
September 26, 2022
Last Updated
September 26, 2022
Sponsor
Michigan State University
Collaborators
Kenya Diabetes Management & Information Centre (DMI)
1. Study Identification
Unique Protocol Identification Number
NCT05560256
Brief Title
Building Capacity in Human-Centered Design: Developing a Diabetes Mobile Health Application for and With Kenyan Adolescents
Official Title
Building Capacity in Human-Centered Design: Developing a Diabetes Mobile Health Application for and With Kenyan Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
Kenya Diabetes Management & Information Centre (DMI)
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
With over 6 billion mobile phone subscribers and 75% of the world having access to a device, global health communities increasingly recognize the potential for using these devices to improve access to health care and health outcomes-especially in sub-Saharan Africa (SSA), where device ownership has grown dramatically. Less attention, however, has been given to developing the research capacity to allow these countries' public health researchers to collaborate with software developers and the users of mobile health applications (henceforth apps) to develop their own interventions. If mobile health apps are to be adopted, effective, and scalable, they must be designed by and with these individuals, the people most knowledgeable about the issues affecting technology use and disease management in their countries. Human-centered design (HCD), or design thinking, is a promising design strategy that prioritizes the needs of the intended population. It has also been successfully used to develop innovative and locally relevant health interventions that improve health outcomes. The purpose of this R21 proposal is to introduce Kenyan public health researchers and software developers to the HCD process and then collaboratively develop and evaluate an mobile health app that targets a growing epidemic among middle-to-late adolescents (13-18 yrs.) in Kenya-Type 1 Diabetes (T1D). To achieve this goal, we will pursue these specific aims: (1) train Kenyan health practitioners and software developers in HCD; (2) use HCD to build a prototype mHealth intervention for adolescents in Kenya with T1D; and (3) assess the prototype's usability, accessibility, and feasibility in using it to increase adolescents' knowledge of T1D and management of the disease. Our long-term goals include: (1) building research capacity by establishing a research network between health researchers at The Kenyan Diabetes Management and Information Center (DMI-a non-profit organization that works with adolescents with T1D) and mobile software developers at Lake Hub (an innovation space) so they can design future mobile health apps; (2) developing a commercially available app that Kenyan adolescents can use to manage T1D and stay healthy; and (3) evaluating the HCD process as it applies to developing mobile health interventions that improve health outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Human-Centered Design, Mobile Phones, Diabetes
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Youth Engage with Diary
Arm Type
Experimental
Arm Description
24 youth will use the Diary for one month
Intervention Type
Other
Intervention Name(s)
Diary/Journal
Other Intervention Name(s)
Diary
Intervention Description
Participants will be given a diary to record their blood glucose measurements, and other pertinent information (diet and activities).
Primary Outcome Measure Information:
Title
Building Capacity in Human-Centered Design: Developing a Diabetes mHealth Application for and with Kenyan Adolescents
Description
Feasibility of Diary
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
T1D diagnosis 13-18 years old
Have an A1c > 7
Uses a phone
Fluent in Swahili
Exclusion Criteria:
Being treated for significant medical condition other than T1D
Being treated for eating disorder
Facility Information:
Facility Name
Nairobi
City
Nairobi
Country
Kenya
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Building Capacity in Human-Centered Design: Developing a Diabetes Mobile Health Application for and With Kenyan Adolescents
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