NCT05560256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

3.5 years

First QC Date

September 26, 2022

Last Update Submit

March 18, 2024

Conditions

Keywords

Human-Centered DesignMobile PhonesDiabetes

Outcome Measures

Primary Outcomes (1)

  • Building Capacity in Human-Centered Design: Developing a Diabetes mHealth Application for and with Kenyan Adolescents

    Feasibility of Diary

    1 month

Study Arms (1)

Youth Engage with Diary

EXPERIMENTAL

24 youth will use the Diary for one month

Other: Diary/Journal

Interventions

Participants will be given a diary to record their blood glucose measurements, and other pertinent information (diet and activities).

Also known as: Diary
Youth Engage with Diary

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • T1D diagnosis 13-18 years old
  • Have an A1c \> 7
  • Uses a phone
  • Fluent in Swahili

You may not qualify if:

  • Being treated for significant medical condition other than T1D
  • Being treated for eating disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nairobi

Nairobi, Kenya

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
We asked participants to interact with the paper diary during a workshop.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 26, 2022

First Posted

September 29, 2022

Study Start

October 1, 2019

Primary Completion

April 15, 2023

Study Completion

April 30, 2023

Last Updated

March 22, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations