An interventional study of mHealth Application in Preconception Care, sponsored by Boston University. Completed at 1 site in Lesotho. Open to female participants aged 18 Years to 28 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-18.
Sponsored by Boston University · Not applicable, Interventional, and Prevention
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.
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.
Boston University is the lead sponsor of 270 studies on the registry; 36 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.
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Exclusion Criteria:
-None
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.
Behavioral: 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.
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
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
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
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
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
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
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
| Milestone | Nthabi mHealth Application |
|---|---|
| Started | 160 |
| Completed | 138 |
| Not completed | 22 |
| Withdrew: Lost to follow-up | 22 |
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.
| percentage change pre to post test | Nthabi mHealth Application |
|---|---|
| Folic acid knowledge | 58.1 |
| Family planning knowledge | 14.8 |
| Healthy eating knowledge | 4.3 |
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.
| percentage strongly agree or agree | Nthabi mHealth Application |
|---|---|
| Ease of Use of Nthabi App | 98.6 |
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.
| percentage strongly agree or agree | Nthabi mHealth Application |
|---|---|
| Nthabi App Health Education Content Organized and Timely | 95.7 |
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.
| percentage strongly agree or agree | Nthabi mHealth Application |
|---|---|
| Able to Complete Tasks Quickly Using Nthabi | 95.7 |
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.
| percentage strongly agree or agree | Nthabi mHealth Application |
|---|---|
| Enjoyed Using the Nthabi App | 96.4 |
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.
| percentage strongly agree or agree | Nthabi mHealth Application |
|---|---|
| Intend to Keep Using the Nthabi App | 92.1 |
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.
| percentage strongly agree or agree | Nthabi mHealth Application |
|---|---|
| The Nthabi App Was Culturally Appropriate | 96.4 |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nthabi mHealth Application | 0/138 (0%) | 0/138 (0%) | 0/138 (0%) |
| Age, Customized(Participants) | Nthabi mHealth Application |
|---|---|
| 18-20 | 34 |
| 21-23 | 53 |
| 24-26 | 37 |
| 27-28 | 14 |
| Sex: Female, Male(Participants) | Nthabi mHealth Application |
|---|---|
| Female | 138 |
| Male | 0 |
| Race and Ethnicity Not Collected(Participants) | Nthabi mHealth Application |
|---|
| Region of Enrollment(participants) | Nthabi mHealth Application |
|---|---|
| Lesotho | 138 |
PDFs hosted by the registry, ClinicalTrials.gov.
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