Type 1 DiabetesNCT05560256
Developing a Diabetes Mobile Health Application for and With Kenyan Adolescents
A study testing Diary/Journal in people with Type 1 Diabetes, run by Michigan State University at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Diary/Journal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteKenya
- Study dates
- 1 Oct 2019to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- T1D diagnosis 13-18 years old
- Have an A1c > 7
- Uses a phone
- Fluent in Swahili
Who cannot join
- Being treated for significant medical condition other than T1D
- Being treated for eating disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Building Capacity in Human-Centered Design: Developing a Diabetes Mobile Health Application for and With Kenyan Adolescents
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.
Read the detailed description
Aim #1 Train Kenyan health practitioners and software developers in HCD. We accomplished this by implementing an HCD curriculum during a three-day workshop with our Kenyan collaborators. Drs. Wyche, Olson and Holtz, travelled to Nairobi, Kenya, between September 28 and October 5 to conduct our three-day training workshop. Our collaborators from LakeHub (in Kisumu) also flew to Nairobi. Our other collaborators-from DMI-are based in Kenya's capital city. We held the workshop at the Ngong Hills Hotel in Nairobi.
Aim #2 Use HCD to build a prototype intervention for adolescents in Kenya with T1D. We accomplished this aim by conducting interviews; analyzing data; holding two design workshops; developing an initial version of a diary; conducting a pilot evaluation of the diary; and iterating upon the diary's design. Significant project outcomes include a personal diary.
In April 2022, Dr. Jennifer Olson, and our collaborators at DMI and ROA, interviewed 24 youth with T1D at two sites in Kenya (Vihiga County and Nairobi); 12 participants in each site. She also interviewed their parents/caregivers (n=22), as well as key stakeholders (e.g., doctors, teachers, community health workers). Interviews were digitally recorded (with participants' consent). During this time, we also provided youth with a digital camera and asked them to engage in a photovoice exercise (i.e., asking participants to take photographs, and then reflecting upon the reasons, emotions and experiences that motivated them to take the photos).
We hired translators-fluent in Kiswahili and English-to translate and transcribe the interviews. We also collected participants' photographs. Drs. Olson and Wyche analyzed this transcribed interviews and photographs in May-June 2022. Our objective was to deepen our understanding of how youth managed T1D and to identify possible technology interventions. A significant finding was that developing a mobile phone application would not support youths' existing practices. Most participants are not allowed to use mobile phones in school. Further, not all participants, especially those living in rural areas, had access to a smart phone.
In July 2022, Drs. Wyche and Olson travelled to Kenya. We held two, two-day design workshops (between July 3 and July 7). The first was held at Sosa Cottages (Majengo); the second was held at Ngong Hills Hotel (Nairobi). All of the youth and caregivers, who Dr. Olson interviewed in April, attended the workshops. Workshop objectives included: learning more about youth and T1D; and brainstorming design interventions that would help youth manage the disease. During these sessions, participants discussed their experiences managing T1D; they also talked about their photographs. Other significant activities include brainstorming exercises. Participants ideas included posters that would educate people about T1D, a calendar that would help youth keep track of their doctors' appointments, and diary that supported T1D-related activities. At the conclusion of the workshops Drs. Wyche and Olson determined that the diary was the most promising intervention. The diary would allow youth to track their sugar levels, as well as what they ate and their activity levels. The diary would also include useful information about how to effectively manage T1D (e.g., how to inject insulin, to make healthy meals, and properly store insulin). They worked with designed from LakeHub to develop an initial version of this diary.
In September 2022, the design team printed 60 initial copies of the diary. During this time, Drs. Wyche and Olson returned to Kenya to share these diaries with doctors, our collaborators (at DMI and ROA), and with the youth and their caregivers. Dr. Wyche met with Drs. Karakezi and Ngugi (DMI) to review the text in the diary. We also held two, daylong workshops-one in Vihiga and one in Nairobi-to introduce the diary to the youth and their parents. Our objective was to get preliminary feedback on how to improve the diary's design. Outcomes of these interviews and workshops included significant insights about changes that would improve the diary (e.g., modifying text, changing images, adding more information).
Aim #3 The final phase of the HCD process is implementation, or the project's formative evaluation phase. In September 2022, we gave the prototype diary to the youth, their caregivers, and other stakeholders who contributed to its development (e.g., doctors, and community health workers). Our objective was to validate the intervention's usefulness as well as the feasibility of using it to increase adolescents' knowledge of T1D and management of the disease. To achieve this goal, we conducted focus groups to assess youth's initial reactions to the diary, asked them to fill out pages (e.g., blood glucose monitoring page), and solicited feedback on the diary's strengths and weaknesses. We also administered a short survey to assess how often the diary was used during a one-month period. Participants' feedback was generally positive. They commented on the diary's professional appearance and noted the inclusion of images that were similar to their context (e.g., illustrations of foods they ate). We also received significant feedback on how to improve the diary. This included adding more information about how to properly store insulin-when you do not have access to a refrigerator-as well as guidance on how to best inject insulin. Survey data suggested frequent use of the diary (i.e., at least once a day).
- Conditions
- Type 1 Diabetes
- Being tested
- Diary/Journal
- Keywords
- Human-Centered Design, Mobile Phones, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diary/JournalOther
Also called Diary
Participants will be given a diary to record their blood glucose measurements, and other pertinent information (diet and activities).
| Study group | Role | What they receive |
|---|---|---|
| Youth Engage with Diary | Experimental | 24 youth will use the Diary for one month Receives: Other: Diary/Journal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Building Capacity in Human-Centered Design: Developing a Diabetes mHealth Application for and with Kenyan Adolescents
Feasibility of Diary
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Oct 2019
- Primary completion15 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Kenyan Diabetes Management & Information Centre (DMI)
- Responsible party
- Principal investigator, Susan Wyche, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560256
- Sponsor's protocol ID
- 1R21TW011339-01
- Status last verified
- Mar 2024
- First submitted
- 26 Sep 2022
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Capacity in Human-Centered Design: Developing a Diabetes Mobile Health Application for and With Kenyan Adolescents
- ClinicalTrials.gov ID
- NCT05560256
- Acronym / sponsor ID
- 1R21TW011339-01
- Conditions
- Type 1 Diabetes
- Keywords
- Human-Centered Design, Mobile Phones, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Kenyan Diabetes Management & Information Centre (DMI)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim #1 Train Kenyan health practitioners and software developers in HCD. We accomplished this by implementing an HCD curriculum during a three-day workshop with our Kenyan collaborators. Drs. Wyche, Olson and Holtz, travelled to Nairobi, Kenya, between September 28 and October 5 to conduct our three-day training workshop. Our collaborators from LakeHub (in Kisumu) also flew to Nairobi. Our other collaborators-from DMI-are based in Kenya's capital city. We held the workshop at the Ngong Hills Hotel in Nairobi.
Aim #2 Use HCD to build a prototype intervention for adolescents in Kenya with T1D. We accomplished this aim by conducting interviews; analyzing data; holding two design workshops; developing an initial version of a diary; conducting a pilot evaluation of the diary; and iterating upon the diary's design. Significant project outcomes include a personal diary.
In April 2022, Dr. Jennifer Olson, and our collaborators at DMI and ROA, interviewed 24 youth with T1D at two sites in Kenya (Vihiga County and Nairobi); 12 participants in each site. She also interviewed their parents/caregivers (n=22), as well as key stakeholders (e.g., doctors, teachers, community health workers). Interviews were digitally recorded (with participants' consent). During this time, we also provided youth with a digital camera and asked them to engage in a photovoice exercise (i.e., asking participants to take photographs, and then reflecting upon the reasons, emotions and experiences that motivated them to take the photos).
We hired translators-fluent in Kiswahili and English-to translate and transcribe the interviews. We also collected participants' photographs. Drs. Olson and Wyche analyzed this transcribed interviews and photographs in May-June 2022. Our objective was to deepen our understanding of how youth managed T1D and to identify possible technology interventions. A significant finding was that developing a mobile phone application would not support youths' existing practices. Most participants are not allowed to use mobile phones in school. Further, not all participants, especially those living in rural areas, had access to a smart phone.
In July 2022, Drs. Wyche and Olson travelled to Kenya. We held two, two-day design workshops (between July 3 and July 7). The first was held at Sosa Cottages (Majengo); the second was held at Ngong Hills Hotel (Nairobi). All of the youth and caregivers, who Dr. Olson interviewed in April, attended the workshops. Workshop objectives included: learning more about youth and T1D; and brainstorming design interventions that would help youth manage the disease. During these sessions, participants discussed their experiences managing T1D; they also talked about their photographs. Other significant activities include brainstorming exercises. Participants ideas included posters that would educate people about T1D, a calendar that would help youth keep track of their doctors' appointments, and diary that supported T1D-related activities. At the conclusion of the workshops Drs. Wyche and Olson determined that the diary was the most promising intervention. The diary would allow youth to track their sugar levels, as well as what they ate and their activity levels. The diary would also include useful information about how to effectively manage T1D (e.g., how to inject insulin, to make healthy meals, and properly store insulin). They worked with designed from LakeHub to develop an initial version of this diary.
In September 2022, the design team printed 60 initial copies of the diary. During this time, Drs. Wyche and Olson returned to Kenya to share these diaries with doctors, our collaborators (at DMI and ROA), and with the youth and their caregivers. Dr. Wyche met with Drs. Karakezi and Ngugi (DMI) to review the text in the diary. We also held two, daylong workshops-one in Vihiga and one in Nairobi-to introduce the diary to the youth and their parents. Our objective was to get preliminary feedback on how to improve the diary's design. Outcomes of these interviews and workshops included significant insights about changes that would improve the diary (e.g., modifying text, changing images, adding more information).
Aim #3 The final phase of the HCD process is implementation, or the project's formative evaluation phase. In September 2022, we gave the prototype diary to the youth, their caregivers, and other stakeholders who contributed to its development (e.g., doctors, and community health workers). Our objective was to validate the intervention's usefulness as well as the feasibility of using it to increase adolescents' knowledge of T1D and management of the disease. To achieve this goal, we conducted focus groups to assess youth's initial reactions to the diary, asked them to fill out pages (e.g., blood glucose monitoring page), and solicited feedback on the diary's strengths and weaknesses. We also administered a short survey to assess how often the diary was used during a one-month period. Participants' feedback was generally positive. They commented on the diary's professional appearance and noted the inclusion of images that were similar to their context (e.g., illustrations of foods they ate). We also received significant feedback on how to improve the diary. This included adding more information about how to properly store insulin-when you do not have access to a refrigerator-as well as guidance on how to best inject insulin. Survey data suggested frequent use of the diary (i.e., at least once a day).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Youth Engage with Diary | Experimental | Other: Diary/Journal24 youth will use the Diary for one month |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- T1D diagnosis 13-18 years old
- Have an A1c > 7
- Uses a phone
- Fluent in Swahili
Key exclusion criteria (2 listed)
- Being treated for significant medical condition other than T1D
- Being treated for eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diary/JournalAlso: DiaryParticipants will be given a diary to record their blood glucose measurements, and other pertinent information (diet and activities). | Other | Youth Engage with Diary |
Primary outcome
Building Capacity in Human-Centered Design: Developing a Diabetes mHealth Application for and with Kenyan Adolescents
Time frame: 1 month
Feasibility of Diary
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diary/Journal in people with Type 1 Diabetes, run by Michigan State University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Building Capacity in Human-Centered Design: Developing a Diabetes mHealth Application for and with Kenyan Adolescents (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.