Preconception Care
Conditions
Keywords
mHealth, Lesotho
Brief summary
This project will determine how well the mobile health (mHealth) Nthabi application is introduced and used at district hospitals in Lesotho. This will help with measuring the effectiveness of an evidence-based mHealth application in a low-income country. Three factors will be studied when assessing the mHealth application's overall impact: 1) end-user content knowledge 2) pre and post stage of change and 3) system usage. This data will be collected by the mHealth application. End-users will use the mHealth application over a period of two months. Results will be shared with the clinical, health services research, information technology, and policy communities.
Detailed description
Lesotho has second-highest HIV and fifth-highest tuberculosis prevalence rates worldwide, and a maternal mortality rate (1024/100,000) that is among the highest in Africa. As there are only 6.2 nurses and 0.5 physicians per 10,000 people, both about one-third of the African average, there is an enormous need for eHealth systems to assist the clinical care system. Preconception care is an effort to focus on engaging young women in their health before they become pregnant since many women enter pregnancy at risk for poor outcomes because of preexisting medical conditions or not following evidence-based preventive action. In 2013, the WHO prioritized research that focuses on developing, delivering, and scaling preconception women's health interventions in low and middle-income countries to optimize health and birth outcomes. The WHO emphasized implementation research as the key step in helping to maximize the coverage and uptake of preconception care to enhance the long-term health outcomes for women and their children. The existing Gabby system is a patient-facing, user-friendly, evidence-based, scalable, culturally adaptive, health communication system designed to improve women's health. The investigator's team has developed and tested several Embodied Conversational Agents (ECAs), which are virtual characters designed using expertise from health communication, psychotherapy, social psychology, sociolinguistics, linguistics, and communication theory. For this project, the investigators will first adapt the existing Gabby system to a culturally appropriate mHealth application, called Nthabi, and second, study the impact of the Nthabi application into district hospitals in Lesotho in partnership with the Lesotho Boston Health Alliance (LeBoHA) using the existing educational infrastructure. The research team will assess the effectiveness of Nthabi based on the periodic stage of change assessments over the two-month implementation, end-user content knowledge, and system usage.
Interventions
BEHAVIORALmHealth Application
Nthabi mHealth Application delivers educational content and recommendations to minimize or eliminate health risks. The content is delivered via the Nthabi application downloaded on an Android phone smartphone. End-users can select from a list of topics relevant to the Lesotho population to engage with the conversational agent, Nthabi, and discuss conditions such as tuberculosis, HIV testing, healthy diet, and family planning.
Sponsors
Fogarty International Center of the National Institute of Health
Boston University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 28 Years
Healthy volunteers
Yes
Inclusion criteria
* Female Resident of Lesotho * English Speaking * Have access to an Android smartphone * Not currently pregnant at time of enrollment
Exclusion criteria
-None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Preconception Health Knowledge | Baseline, 4 weeks | Change in preconception health knowledge will be assessed by a change in the percentage correct scores between the Pre and Post tests which were developed by the investigator. Higher positive change scores suggest more knowledge about preconception health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nthabi App Health Education Content Organized and Timely | 4 weeks | This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results. |
| Able to Complete Tasks Quickly Using Nthabi | 4 weeks | This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results. |
| Ease of Use of Nthabi App | 4 weeks | This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results. |
| Intend to Keep Using the Nthabi App | 4 weeks | This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results. |
| The Nthabi App Was Culturally Appropriate | 4 weeks | This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results. |
| Enjoyed Using the Nthabi App | 4 weeks | This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results. |
Countries
Lesotho
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nthabi mHealth Application About 20 women from each of the ten district hospitals will be recruited. Each district hospital will have a separate administrative page on the Nthabi server where women will be enrolled with a unique username and password. Upon enrollment, the women will be asked to engage with Nthabi for two months to discuss the relevant content areas they are interested in learning more about.
mHealth Application: Nthabi mHealth Application delivers educational content and recommendations to minimize or eliminate health risks. The content is delivered via the Nthabi application downloaded on an Android phone smartphone. End-users can select from a list of topics relevant to the Lesotho population to engage with the conversational agent, Nthabi, and discuss conditions such as tuberculosis, HIV testing, healthy diet, and family planning. | 138 |
| Total | 138 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 22 |
Baseline characteristics
| Characteristic | Nthabi mHealth Application | — |
|---|---|---|
| Age, Customized 18-20 | 34 Participants | — |
| Age, Customized 21-23 | 53 Participants | — |
| Age, Customized 24-26 | 37 Participants | — |
| Age, Customized 27-28 | 14 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Lesotho | 138 participants | — |
| Sex: Female, Male Female | 138 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 138 |
| other Total, other adverse events | 0 / 138 |
| serious Total, serious adverse events | 0 / 138 |
Outcome results
Primary
Change in Preconception Health Knowledge
Change in preconception health knowledge will be assessed by a change in the percentage correct scores between the Pre and Post tests which were developed by the investigator. Higher positive change scores suggest more knowledge about preconception health.
Time frame: Baseline, 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nthabi mHealth Application | Change in Preconception Health Knowledge | Folic acid knowledge | 58.1 percentage change pre to post test |
| Nthabi mHealth Application | Change in Preconception Health Knowledge | Family planning knowledge | 14.8 percentage change pre to post test |
| Nthabi mHealth Application | Change in Preconception Health Knowledge | Healthy eating knowledge | 4.3 percentage change pre to post test |
Secondary
Able to Complete Tasks Quickly Using Nthabi
This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nthabi mHealth Application | Able to Complete Tasks Quickly Using Nthabi | 95.7 percentage strongly agree or agree |
Secondary
Ease of Use of Nthabi App
This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nthabi mHealth Application | Ease of Use of Nthabi App | 98.6 percentage strongly agree or agree |
Secondary
Enjoyed Using the Nthabi App
This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nthabi mHealth Application | Enjoyed Using the Nthabi App | 96.4 percentage strongly agree or agree |
Secondary
Intend to Keep Using the Nthabi App
This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nthabi mHealth Application | Intend to Keep Using the Nthabi App | 92.1 percentage strongly agree or agree |
Secondary
Nthabi App Health Education Content Organized and Timely
This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nthabi mHealth Application | Nthabi App Health Education Content Organized and Timely | 95.7 percentage strongly agree or agree |
Secondary
The Nthabi App Was Culturally Appropriate
This outcome was assessed by responses to a specific question in an investigator developed survey containing 22 questions eliciting responses on a 4-point Likert scale (strongly agree, agree, disagree, and strongly disagree). The higher the percentage of strongly agree or agree responses the more favorable the results.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nthabi mHealth Application | The Nthabi App Was Culturally Appropriate | 96.4 percentage strongly agree or agree |