TelemedicineNCT04863521
Evaluation of MHP 3.0 in Two Clinical Settings
A study testing MHP in people with Telemedicine, run by Naima Health LLC at 1 site in United States.
Trial summary
The purpose of this study is to assess the acceptability and feasibility of the use of MyHealthyPregnancy (MHP) 3.0 in clinical practice over a 1 year period of time. The investigators will pilot MHP 3.0 (Spanish and English language options) at practice sites at the Obstetrix Medical Group of Houston, Texas and the… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Telemedicine
- What is being tested?
- MHP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2022to 31 Mar 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is at least 18 years of age
- Currently pregnant and in gestational week 12 or less
- Is under the care of a participating provider/clinic
- Owns a smartphone
- Spanish or English native speaker
Who cannot join
- Under 18 years of age
- Not pregnant at time of enrollment
- Is pregnant but over 12 weeks of gestational age
- Provider is not part of the study
- Does not own a smartphone
- Native language is not Spanish or English
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Obstetrix Medical Center Houston
Houston, Texas, 77477
Olaide Ashimi, MD, 412-587-3409, olaide.ashimibalogun@pediatrix.com
About this study
Official title: Pilot MHP 3.0 in Two Clinical Settings to Evaluate Acceptability and Feasibility of MHP
The purpose of this study is to assess the acceptability and feasibility of the use of MyHealthyPregnancy (MHP) 3.0 in clinical practice over a 1 year period of time. The investigators will pilot MHP 3.0 (Spanish and English language options) at practice sites at the Obstetrix Medical Group of Houston, Texas and the UPMC (University of Pittsburgh Medical Center) Healthcare System. Patient and care team feedback will be assessed throughout this study. Patients at Obstetrix Medical Group of Houston will be assessed using 4 short acceptability and feasibility surveys administered by the Naima Health team using a link for an online survey during the study term: at baseline, week 14-18, week 24-28, and week 34-36. A subset of participants at UPMC will also be asked to complete user surveys.
Read the detailed description
For this study the investigators pilot MHP products in two clinical settings to determine their acceptability and feasibility in clinical practice. The investigators will pilot MHP 3.0 (Spanish and English language options) at practice sites at the Obstetrix Medical Group of Houston, Texas and the UPMC Healthcare System. Participants will receive MHP to use as part of their prenatal care, along with communication from the prescribing provider about how the app will be used and when the provider will have access to their information.
Population and Sample Size: The investigators will recruit a sample of 75 patients from the Obstetrix Medical Group clinical sites in women's first trimester of pregnancy. The investigators will over sample for Spanish speakers (approximately 20% of our population). Women will be eligible for recruitment if they are at least 18 years old, are currently pregnant and under the care of a participating provider/clinic, own a smartphone, and are literate in English or Spanish. We will recruit 75 patients patients who are currently using MHP as part of their routine care at the UPMC Healthcare system to complete a user online survey to discuss their experience with the app.
At Obstetrix Medical Group of Houston, recruitment staff will identify eligible women to match our demographic requirements, introduce the study during an initial prenatal appointment, and then consent women to the study.
Data sources and collection:
Patients at Obstetrix Medical Group of Houston: A short acceptability and feasibility survey will be administered by the Naima Health team online four times during the study term. A final interview will be conducted by phone between weeks 36-42 with a sample of 10 - 15 study participants.
Patients at UPMC Healthcare system: Patients who have been prescribed the app as part of their routine care will be invited to participate in an online survey.
Analytic Plan and Sample Size Considerations:
The investigators will focus on feasibility (a priori defined as ≥ 67% completion of weekly questionnaires administered through the app) and acceptability (a priori defined as satisfaction scores of ≥ 4 on a 7-point Likert scale among ≥80% participants) as primary outcomes for this aim. Descriptive statistics will be used to characterize baseline demographic characteristics of the participants. The investigators will use point estimates (i.e. means and sample proportions) and 95% confidence intervals to characterize the sample with respect to baseline demographic characteristics. Debriefing interview transcripts will be coded for themes of acceptability, satisfaction, and barriers to app use.
- Conditions
- Telemedicine
- Being tested
- MHP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHPOther
MyHealthyPregnancy app (MHP 3.0) is a mHealth app specifically focused on detection and referral for depression and IPV (Intimate Partner Violence) risk, in addition to its other pregnancy risk detection and support features.
| Study group | Role | What they receive |
|---|---|---|
| MHP Users | Experimental | A subset of the population within the clinical setting will be requested to participate in this pilot while the rest of the population will receive standard of care. Receives: Other: MHP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of patients that screen positive
Measured by the number of patients who screen positive for depression and/or intimate partner violence through the app compared to the number of patients who have screened positive for depression and/or intimate partner violence historically through routine prenatal care. Higher numbers mean better outcomes.
Measured: 8 months
Percentage of questionnaires completed
Measured by calculating the percentage of questionnaires completed by each user from the total administered through the MHP app. Values would range from 0% to 100%. Higher numbers mean better outcomes.
Measured: 8 months
Usability Questionnaire
This questionnaire will assess subjective opinions about the usability of MHP. This questionnaire includes 7 questions that will use a Likert scale anchored from 1/strongly disagree to 5/strongly agree. The minimum value is 7 and the maximum value of 35. Higher numbers mean better outcomes.
Measured: 8 months
Acceptability Questionnaire
This questionnaire will assess subjective opinions about the acceptability of the content in MHP. This questionnaire includes 6 questions that will use a Likert scale anchored from 1/strongly disagree to 5/strongly agree. The minimum value is 6 and the maximum value of 30. Higher numbers mean better outcomes.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start20 Jun 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Users recruited at Obstetrix Medical Group of Houston will participate in a pilot study that includes facilitating access to the app and will be followed throughout their pregnancy using online surveys. Users at the UPMC Healthcare System are already using the app as part of their routine care and will be asked to complete an online survey about their user experience.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naima Health LLC
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Obstetrix Medical Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863521
- Sponsor's protocol ID
- CDC-PHASEII-003
- Status last verified
- Aug 2022
- First submitted
- 16 Apr 2021
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot MHP 3.0 in Two Clinical Settings to Evaluate Acceptability and Feasibility of MHP
- ClinicalTrials.gov ID
- NCT04863521
- Acronym / sponsor ID
- CDC-PHASEII-003
- Conditions
- Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Naima Health LLCUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Obstetrix Medical Group
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 28 Apr 2021 (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.
The purpose of this study is to assess the acceptability and feasibility of the use of MyHealthyPregnancy (MHP) 3.0 in clinical practice over a 1 year period of time. The investigators will pilot MHP 3.0 (Spanish and English language options) at practice sites at the Obstetrix Medical Group of Houston, Texas and the UPMC (University of Pittsburgh Medical Center) Healthcare System. Patient and care team feedback will be assessed throughout this study. Patients at Obstetrix Medical Group of Houston will be assessed using 4 short acceptability and feasibility surveys administered by the Naima Health team using a link for an online survey during the study term: at baseline, week 14-18, week 24-28, and week 34-36. A subset of participants at UPMC will also be asked to complete user surveys.
Detailed description
For this study the investigators pilot MHP products in two clinical settings to determine their acceptability and feasibility in clinical practice. The investigators will pilot MHP 3.0 (Spanish and English language options) at practice sites at the Obstetrix Medical Group of Houston, Texas and the UPMC Healthcare System. Participants will receive MHP to use as part of their prenatal care, along with communication from the prescribing provider about how the app will be used and when the provider will have access to their information.
Population and Sample Size: The investigators will recruit a sample of 75 patients from the Obstetrix Medical Group clinical sites in women's first trimester of pregnancy. The investigators will over sample for Spanish speakers (approximately 20% of our population). Women will be eligible for recruitment if they are at least 18 years old, are currently pregnant and under the care of a participating provider/clinic, own a smartphone, and are literate in English or Spanish. We will recruit 75 patients patients who are currently using MHP as part of their routine care at the UPMC Healthcare system to complete a user online survey to discuss their experience with the app.
At Obstetrix Medical Group of Houston, recruitment staff will identify eligible women to match our demographic requirements, introduce the study during an initial prenatal appointment, and then consent women to the study.
Data sources and collection:
Patients at Obstetrix Medical Group of Houston: A short acceptability and feasibility survey will be administered by the Naima Health team online four times during the study term. A final interview will be conducted by phone between weeks 36-42 with a sample of 10 - 15 study participants.
Patients at UPMC Healthcare system: Patients who have been prescribed the app as part of their routine care will be invited to participate in an online survey.
Analytic Plan and Sample Size Considerations:
The investigators will focus on feasibility (a priori defined as ≥ 67% completion of weekly questionnaires administered through the app) and acceptability (a priori defined as satisfaction scores of ≥ 4 on a 7-point Likert scale among ≥80% participants) as primary outcomes for this aim. Descriptive statistics will be used to characterize baseline demographic characteristics of the participants. The investigators will use point estimates (i.e. means and sample proportions) and 95% confidence intervals to characterize the sample with respect to baseline demographic characteristics. Debriefing interview transcripts will be coded for themes of acceptability, satisfaction, and barriers to app use.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Users recruited at Obstetrix Medical Group of Houston will participate in a pilot study that includes facilitating access to the app and will be followed throughout their pregnancy using online surveys. Users at the UPMC Healthcare System are already using the app as part of their routine care and will be asked to complete an online survey about their user experience.
| Arm | Type | Receives |
|---|---|---|
| MHP Users | Experimental | Other: MHPA subset of the population within the clinical setting will be requested to participate in this pilot while the rest of the population will receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is at least 18 years of age
- Currently pregnant and in gestational week 12 or less
- Is under the care of a participating provider/clinic
- Owns a smartphone
- Spanish or English native speaker
Key exclusion criteria (6 listed)
- Under 18 years of age
- Not pregnant at time of enrollment
- Is pregnant but over 12 weeks of gestational age
- Provider is not part of the study
- Does not own a smartphone
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 |
|---|---|---|
| MHPMyHealthyPregnancy app (MHP 3.0) is a mHealth app specifically focused on detection and referral for depression and IPV (Intimate Partner Violence) risk, in addition to its other pregnancy risk detection and support features. | Other | MHP Users |
Primary outcome
Change in number of patients that screen positive
Time frame: 8 months
Measured by the number of patients who screen positive for depression and/or intimate partner violence through the app compared to the number of patients who have screened positive for depression and/or intimate partner violence historically through routine prenatal care. Higher numbers mean better outcomes.
Percentage of questionnaires completed
Time frame: 8 months
Measured by calculating the percentage of questionnaires completed by each user from the total administered through the MHP app. Values would range from 0% to 100%. Higher numbers mean better outcomes.
Usability Questionnaire
Time frame: 8 months
This questionnaire will assess subjective opinions about the usability of MHP. This questionnaire includes 7 questions that will use a Likert scale anchored from 1/strongly disagree to 5/strongly agree. The minimum value is 7 and the maximum value of 35. Higher numbers mean better outcomes.
Acceptability Questionnaire
Time frame: 8 months
This questionnaire will assess subjective opinions about the acceptability of the content in MHP. This questionnaire includes 6 questions that will use a Likert scale anchored from 1/strongly disagree to 5/strongly agree. The minimum value is 6 and the maximum value of 30. Higher numbers mean better outcomes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MHP in people with Telemedicine, run by Naima Health LLC 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 6 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: status not confirmed, as of the sponsor's last update on 12 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anabel F Castillo, PhD (4125873409, anabel@naimahealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of patients that screen positive (time frame: 8 months). The study lists 4 primary outcomes in all. 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 12 Aug 2022.