Preconception CareNCT01827215
Randomized Control Trial of a Virtual Patient Advocate for Preconception Care
A study testing Virtual Patient Advocate (VPA) in people with Preconception Care, run by Boston Medical Center at 1 site in United States.
Trial summary
This study is to examine the effectiveness of a health communication system (Gabby) that assesses preconception health risks and tailors the education and intervention to each subject, based on her health risks. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preconception Care
- What is being tested?
- Virtual Patient Advocate (VPA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jan 2019
- 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 18 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Between the ages of 18-34
- Self-identify as Black or African American
- Have a phone and are willing to receive study-related phone calls
- Have access to a computer with internet
Who cannot join
- Do not speak English
- Self-reported pregnant at the time of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Innovative Communication Technology to Improve the Health of Young African American Women
This study is to examine the effectiveness of a health communication system (Gabby) that assesses preconception health risks and tailors the education and intervention to each subject, based on her health risks. This project specifically targets young Black or African American women in order to reduce major disparities in birth outcomes. Clinicians do not have time to assess for the over 100 preconception health risks that can impact birth outcomes; the investigators system can streamline that assessment and create a personalized list of risks. Patients can then share their list with clinicians to make their healthcare visits more effective.
The investigators will conduct a two-armed randomized controlled trial (RCT) designed to enroll 530 African American women ages 18-34. After all subjects complete a comprehensive preconception health risk assessment, the intervention group will be trained to use the Gabby system and encouraged to use it at least monthly for one year. The control group will receive a letter listing the risks identified and they will be encouraged to see their clinician to discuss them.
The investigators primary hypothesis will test whether the Gabby system will result in a lower rate of preconception health risks, as defined by CDC, as compared to the control group after 12 months. Secondary outcomes include: measurement of usage rates, dose of exposure, attrition, subject and healthcare provider satisfaction, and number of women with a personalized health plan.
Read the detailed description
The investigators will conduct a two-armed randomized controlled trial designed to enroll 530 African American women ages 18-34. After all subjects complete enrollment forms a comprehensive preconception health risk assessment, the intervention group will be trained to use the Gabby system and encouraged to use it at least monthly for one year.The control group will receive a letter listing the risks identified and they will be encouraged to see their clinician to discuss them.
System Preparation: Dr. Bickmore and the technical team will be responsible for preparing the system for the trial, using the preconception care content and scripts developed by Dr. Jack and the research team. Both teams will meet as the working group to discuss final preparation and modifications.
Usability Testing: As software development is complete, the investigators will conduct thorough usability testing of the interventions and the RCT protocols, using approximately 20 subjects who meet the enrollment criteria of the study. The subjects will use the Gabby system in the investigators research offices to complete the health risk assessment and to begin the interaction about individual risk factors. This session will last no more than one hour. Then they will use the Gabby system online in their home for two weeks; their interactions with the system will include: learning about their individual preconception health risks, managing their "My Health To-Do List," writing stories about their experiences with their health risks, and listening to stories left by other users. Usability subjects will be given a structured log sheet that lists each part of the intervention with space for them to record their reactions and concerns. Research staff (including representatives of both the technical and clinical staff) will review the log sheets. Then individual interviews examining their perceptions of the Gabby system will be conducted by Dr.Yinusa-Nyahkoon using a semi-structured interview guide (see attached Semi-Structured Interview Guide). Dr. Yinusa-Nyahkoon will recommend design and content changes based on interviews. These usability-testers will be paid for their participation and will not participate in the RCT. The investigators anticipate needing to implement a round of system modifications based on subject feedback.
RCT: All RCT participants will be screened for eligibility criteria (see section 21), give consent to participate, and complete baseline data collection forms, including the online Preconception Health Risk Assessment.
Randomization. Using a random numbers table, the statistician (Dr. Chetty) will prepare a numbered set of sealed study allocation envelopes prior to study start. Block randomization will be used to ensure that an equal number of subjects are randomized in each age group.
The Control Group. The control group will receive a letter listing the preconception risks identified in the risk assessment and they will be encouraged to see their clinician to discuss them.
The Intervention Group. Intervention participants from the RCT will be given a username and secure password to log on to the Gabby site for the 12 months of the intervention. They will be encouraged to log on at least monthly, but using the system is voluntary. They will be given the contact information of the Program Manager in the event that they have any issues or questions about the system. The research team will call each intervention participant after 12 months to conduct a follow-up phone call to collect outcome data. At that point, intervention participants will be invited to participate a focus group session, as described below.
Focus Groups. Intervention participants from the RCT will be asked during their follow-up phone call if they would like to participate in a focus group. Each focus group session will last no more than 2 hours and will have no more than 10 participants; the investigators hope to enroll approximately 35 participants in total. Dr. Yinusa-Nyahkoon will conduct the focus group discussion to gather feedback about the system and suggestions for future improvement. All focus group participants will be invited to participate in an additional one-on-one individual interview with Dr. Yinusa-Nyahkoon.
Individual Interviews. Dr. Yinusa-Nyahkoon will conduct the individual interviews using a semi-structured interview guide (see attached Semi-Structured Interview Guide). Each interview will last no more than one hour. All focus group participants will be eligible to sign up for an individual interviews; participation is voluntary.
Interviews with Health Care Providers. Dr. Yinusa-Nyahkoon will conduct one-on-one interviews with health care providers. Only the providers of individual interview participants will be contacted by email for participation. Each health care provider interview will last no more than one hour.
Applying the Intervention. After randomization, the study staff will provide a brief tutorial to the participants in the intervention group explaining how to use the Gabby system and provide a secure username and password to each participant. After completing the tutorial, the participant will be asked to interact with Gabby at least monthly for the next 12 months. They will be given the email address of the project staff so they can ask questions about how to use the system. The project staff will send an email to participants every two weeks to remind them to use the system. Twelve months after enrollment, study staff will call each participant to conduct a follow-up phone interview to collect outcome data.
- Conditions
- Preconception Care
- Being tested
- Virtual Patient Advocate (VPA)
- Keywords
- Preconception Care, Racial Disparities, Health Information Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Patient Advocate (VPA)Behavioural
Intervention participants will have access to the Virtual Patient Advocate (VPA) system for a period of 12 months. They will be encouraged to log on every two weeks or twice a month, but frequency and duration of conversations with the VPA is at the discretion of the participant.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Virtual Patient Advocate) | Experimental | The Intervention Virtual Patient Advocate (VPA) Group participants will be given a username and secure password to log on to the Gabby site for the 12 months of the intervention. They will be encouraged to log on every two weeks or twice a month, but using the system is voluntary. They will be given the contact information of the Program Manager in the event that they have any issues or questions about the system. The research team will call each intervention participant after 6 and 12 months to conduct a follow-up phone call to collect outcome data. At the end of the intervention period, intervention participants will be invited to participate a focus group session. Receives: Behavioral: Virtual Patient Advocate (VPA) |
| Control (Letter) | No intervention | The control group will receive a letter listing the preconception risks identified in the risk assessment and they will be encouraged to see their clinician to discuss them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Number of Preconception Risks
Our primary hypothesis will test whether the Gabby system will result in a lower rate of preconception health risks, as defined by CDC, as compared to the control group after 12 months.
Measured: Baseline and at 12 months after enrollment
Secondary outcomes (3)
Dose of Exposure to Virtual Patient Advocate (VPA) System
Frequency of exposure (in other words, number of log-ins) to the VPA system over the course of 12 months. Duration of log-ins will also be considered (average duration of log-in, minimum and maximum duration observed, etc).
Measured: 12 months after enrollement (data gathered by online system throughout the 12 month intervention period)
Subject Satisfaction with Virtual Patient Advocate (VPA) system
We will administer a satisfaction survey to all intervention participants to measure their level of satisfaction with the system overall, with the VPA character, and also with specific features of the system.
Measured: 12 months after enrollment
Healthcare Provider Satisfaction
We will conduct qualitative interviews with the health care providers of intervention participants, to gather feedback about how the interaction with the VPA did or did not affect the patient-provider interaction.
Measured: Following the participant's appointment with a primary care provider, at any point during the 12 month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preconception CareStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 528 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Northeastern University, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Brian Jack, Boston Medical Center
- Investigators
- Brian W Jack, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827215
- Sponsor's protocol ID
- H-31633
- Other IDs
- R01MD006213
- Status last verified
- Oct 2019
- First submitted
- 5 Apr 2013
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gardiner P, Bickmore T, Yinusa-Nyahkoon L, Reichert M, Julce C, Sidduri N, Martin-Howard J, Woodhams E, Aryan J, Zhang Z, Fernandez J, Loafman M, Srinivasan J, Cabral H, Jack BW. Using Health Information Technology to Engage African American Women on Nutrition and Supplement Use During the Preconception Period. Front Endocrinol (Lausanne). 2021 Jan 19;11:571705. doi: 10.3389/fendo.2020.571705. eCollection 2020.
PubMed 33584534Jack BW, Bickmore T, Yinusa-Nyahkoon L, Reichert M, Julce C, Sidduri N, Martin-Howard J, Zhang Z, Woodhams E, Fernandez J, Loafman M, Cabral HJ. Improving the health of young African American women in the preconception period using health information technology: a randomised controlled trial. Lancet Digit Health. 2020 Sep;2(9):e475-e485. doi: 10.1016/S2589-7500(20)30189-8.
PubMed 33328115
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Innovative Communication Technology to Improve the Health of Young African American Women
- ClinicalTrials.gov ID
- NCT01827215
- Acronym / sponsor ID
- H-31633
- Conditions
- Preconception Care
- Keywords
- Preconception Care, Racial Disparities, Health Information Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Northeastern University, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Sep 2013 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 9 Apr 2013 (estimated)
- 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.
This study is to examine the effectiveness of a health communication system (Gabby) that assesses preconception health risks and tailors the education and intervention to each subject, based on her health risks. This project specifically targets young Black or African American women in order to reduce major disparities in birth outcomes. Clinicians do not have time to assess for the over 100 preconception health risks that can impact birth outcomes; the investigators system can streamline that assessment and create a personalized list of risks. Patients can then share their list with clinicians to make their healthcare visits more effective.
The investigators will conduct a two-armed randomized controlled trial (RCT) designed to enroll 530 African American women ages 18-34. After all subjects complete a comprehensive preconception health risk assessment, the intervention group will be trained to use the Gabby system and encouraged to use it at least monthly for one year. The control group will receive a letter listing the risks identified and they will be encouraged to see their clinician to discuss them.
The investigators primary hypothesis will test whether the Gabby system will result in a lower rate of preconception health risks, as defined by CDC, as compared to the control group after 12 months. Secondary outcomes include: measurement of usage rates, dose of exposure, attrition, subject and healthcare provider satisfaction, and number of women with a personalized health plan.
Detailed description
The investigators will conduct a two-armed randomized controlled trial designed to enroll 530 African American women ages 18-34. After all subjects complete enrollment forms a comprehensive preconception health risk assessment, the intervention group will be trained to use the Gabby system and encouraged to use it at least monthly for one year.The control group will receive a letter listing the risks identified and they will be encouraged to see their clinician to discuss them.
System Preparation: Dr. Bickmore and the technical team will be responsible for preparing the system for the trial, using the preconception care content and scripts developed by Dr. Jack and the research team. Both teams will meet as the working group to discuss final preparation and modifications.
Usability Testing: As software development is complete, the investigators will conduct thorough usability testing of the interventions and the RCT protocols, using approximately 20 subjects who meet the enrollment criteria of the study. The subjects will use the Gabby system in the investigators research offices to complete the health risk assessment and to begin the interaction about individual risk factors. This session will last no more than one hour. Then they will use the Gabby system online in their home for two weeks; their interactions with the system will include: learning about their individual preconception health risks, managing their "My Health To-Do List," writing stories about their experiences with their health risks, and listening to stories left by other users. Usability subjects will be given a structured log sheet that lists each part of the intervention with space for them to record their reactions and concerns. Research staff (including representatives of both the technical and clinical staff) will review the log sheets. Then individual interviews examining their perceptions of the Gabby system will be conducted by Dr.Yinusa-Nyahkoon using a semi-structured interview guide (see attached Semi-Structured Interview Guide). Dr. Yinusa-Nyahkoon will recommend design and content changes based on interviews. These usability-testers will be paid for their participation and will not participate in the RCT. The investigators anticipate needing to implement a round of system modifications based on subject feedback.
RCT: All RCT participants will be screened for eligibility criteria (see section 21), give consent to participate, and complete baseline data collection forms, including the online Preconception Health Risk Assessment.
Randomization. Using a random numbers table, the statistician (Dr. Chetty) will prepare a numbered set of sealed study allocation envelopes prior to study start. Block randomization will be used to ensure that an equal number of subjects are randomized in each age group.
The Control Group. The control group will receive a letter listing the preconception risks identified in the risk assessment and they will be encouraged to see their clinician to discuss them.
The Intervention Group. Intervention participants from the RCT will be given a username and secure password to log on to the Gabby site for the 12 months of the intervention. They will be encouraged to log on at least monthly, but using the system is voluntary. They will be given the contact information of the Program Manager in the event that they have any issues or questions about the system. The research team will call each intervention participant after 12 months to conduct a follow-up phone call to collect outcome data. At that point, intervention participants will be invited to participate a focus group session, as described below.
Focus Groups. Intervention participants from the RCT will be asked during their follow-up phone call if they would like to participate in a focus group. Each focus group session will last no more than 2 hours and will have no more than 10 participants; the investigators hope to enroll approximately 35 participants in total. Dr. Yinusa-Nyahkoon will conduct the focus group discussion to gather feedback about the system and suggestions for future improvement. All focus group participants will be invited to participate in an additional one-on-one individual interview with Dr. Yinusa-Nyahkoon.
Individual Interviews. Dr. Yinusa-Nyahkoon will conduct the individual interviews using a semi-structured interview guide (see attached Semi-Structured Interview Guide). Each interview will last no more than one hour. All focus group participants will be eligible to sign up for an individual interviews; participation is voluntary.
Interviews with Health Care Providers. Dr. Yinusa-Nyahkoon will conduct one-on-one interviews with health care providers. Only the providers of individual interview participants will be contacted by email for participation. Each health care provider interview will last no more than one hour.
Applying the Intervention. After randomization, the study staff will provide a brief tutorial to the participants in the intervention group explaining how to use the Gabby system and provide a secure username and password to each participant. After completing the tutorial, the participant will be asked to interact with Gabby at least monthly for the next 12 months. They will be given the email address of the project staff so they can ask questions about how to use the system. The project staff will send an email to participants every two weeks to remind them to use the system. Twelve months after enrollment, study staff will call each participant to conduct a follow-up phone interview to collect outcome data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Virtual Patient Advocate) | Experimental | Behavioral: Virtual Patient Advocate (VPA)The Intervention Virtual Patient Advocate (VPA) Group participants will be given a username and secure password to log on to the Gabby site for the 12 months of the intervention. They will be encouraged to log on every two weeks or twice a month, but using the system is voluntary. They will be given the contact information of the Program Manager in the event that they have any issues or questions about the system. The research team will call each intervention participant after 6 and 12 months to conduct a follow-up phone call to collect outcome data. At the end of the intervention period, intervention participants will be invited to participate a focus group session. |
| Control (Letter) | No intervention | –The control group will receive a letter listing the preconception risks identified in the risk assessment and they will be encouraged to see their clinician to discuss them. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female
- Between the ages of 18-34
- Self-identify as Black or African American
- Have a phone and are willing to receive study-related phone calls
- Have access to a computer with internet
Key exclusion criteria (2 listed)
- Do not speak English
- Self-reported pregnant at the time of enrollment
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 |
|---|---|---|
| Virtual Patient Advocate (VPA)Intervention participants will have access to the Virtual Patient Advocate (VPA) system for a period of 12 months. They will be encouraged to log on every two weeks or twice a month, but frequency and duration of conversations with the VPA is at the discretion of the participant. | Behavioural | Intervention (Virtual Patient Advocate) |
Primary outcome
Reduction in Number of Preconception Risks
Time frame: Baseline and at 12 months after enrollment
Our primary hypothesis will test whether the Gabby system will result in a lower rate of preconception health risks, as defined by CDC, as compared to the control group after 12 months.
3 secondary outcomes
Dose of Exposure to Virtual Patient Advocate (VPA) System
Time frame: 12 months after enrollement (data gathered by online system throughout the 12 month intervention period)
Subject Satisfaction with Virtual Patient Advocate (VPA) system
Time frame: 12 months after enrollment
Healthcare Provider Satisfaction
Time frame: Following the participant's appointment with a primary care provider, at any point during the 12 month intervention period
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 3 Oct 2019.
- Derived from this study: PubMed 33584534Gardiner P, Bickmore T, Yinusa-Nyahkoon L, Reichert M, Julce C, Sidduri N, Martin-Howard J, Woodhams E, Aryan J, Zhang Z, Fernandez J, Loafman M, Srinivasan J, Cabral H, Jack BW. Using Health Information Technology to Engage African American Women on Nutrition and Supplement Use During the Preconception Period. Front Endocrinol (Lausanne). 2021 Jan 19;11:571705. doi: 10.3389/fendo.2020.571705. eCollection 2020.
- Derived from this study: PubMed 33328115Jack BW, Bickmore T, Yinusa-Nyahkoon L, Reichert M, Julce C, Sidduri N, Martin-Howard J, Zhang Z, Woodhams E, Fernandez J, Loafman M, Cabral HJ. Improving the health of young African American women in the preconception period using health information technology: a randomised controlled trial. Lancet Digit Health. 2020 Sep;2(9):e475-e485. doi: 10.1016/S2589-7500(20)30189-8.
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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.
Brian W Jack, MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Patient Advocate (VPA) in people with Preconception Care, run by Boston Medical Center at 1 site in United States.
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 5 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 3 Oct 2019. 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 United States. 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?
Reduction in Number of Preconception Risks (time frame: Baseline and at 12 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01827215, which also lists 2 linked publications.
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 3 Oct 2019.