Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05560256 |
| Other study ID # |
1R21TW011339-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2019 |
| Est. completion date |
April 30, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Michigan State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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).
