PregnancyNCT03305003
Evaluating How a Mobile App Can Improve Prenatal Care
A study testing Spiral notebook and Mobile application in people with Pregnancy, run by Henry M. Jackson Foundation for the Advancement of Military Medicine.
Trial summary
Throughout the Military Health System, pregnant mothers are issued a spiral-bound guide that provides week by week information about pregnancy, preventive health messages, appointment information, and space to record their experiences throughout their pregnancy. 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
- Pregnancy
- What is being tested?
- Spiral notebook and Mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 31 Dec 2015
- 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
- Women (older than 18 years) who initiate obstetrics care (in the Women's Health or Family Health clinics) at the three sites.
Who cannot join
- Exclusion criteria in this study follow the guidelines for patients who are escalated in obstetrical care, to include…
- Cardiovascular disease
- Cardiac abnormality
- Diabetes Mellitus - Type I or Type II
- Renal disorder
- Uncontrolled hypertension
Show all 23Show fewer
- HIV positive
- Hepatitis B or C positive
- History of syphilis/RPR positive
- Uncontrolled thyroid disease
- History of previous bariatric surgery
- Hematologic conditional with the exception of mild anemia
- Cancer: current or recurrent
- History of seizure disorder or other neurological condition
- History of lupus or other autoimmune disorder
- Antiphospholipid syndrome
- History of transplant
- History of genetics disease with known effect on pregnancy
- Chronic pulmonary disease with the exception of well controlled
- History of inflammatory bowel disease
- Thromboembolic disease: current or previous
- Recurrent pregnancy loss
- History of isoimmunization
About this study
Official title: Evaluating How a Mobile App Can Improve Prenatal Care: A Randomized Controlled Trial
Throughout the Military Health System, pregnant mothers are issued a spiral-bound guide that provides week by week information about pregnancy, preventive health messages, appointment information, and space to record their experiences throughout their pregnancy. When used accordingly, the evidence-based guide is an effective tool for motivating patients to participate in their own healthcare and achieve care goals. However, the spiral-bound paper modality results in patients forgetting the book for appointments or losing it. By testing a mobile application (app) from the current publication, the MHS leverages the efforts which created the guide while increasing patient and provider use.
The multisite testing (randomized controlled trial) of a mobile application developed from the current spiral-bound "Pregnancy and Childbirth: A Goal Oriented Guide to Prenatal Care" created by the VA and DoD provides an innovative, cost-effective opportunity to improve provider-patient communication and patient care.
Read the detailed description
The study was conducted in the women's health and family medicine departments of one community hospital and two medical centers across three states (Georgia, Nevada, and Virginia). In this hospital system, women are distributed a spiral notebook at their obstetric care intake appointment, which generally is scheduled for 8-10 weeks gestation. The spiral notebook is designed for two purposes: 1) patient education of what happens throughout pregnancy, and 2) patient record keeping of the patient's own pregnancy experience, including space for recording weight, blood pressure, and journaling about what they experience between prenatal appointments. The mobile app used in this study was designed for the same two purposes and contained identical content, though through a mobile design interface (available on both Android and iOS platforms). After the pilot study, patient feedback on the mobile app was used to create a beta version. Notable differences were a feature for users to change font size, a search function, and weekly reminders. No substantive content changed. This randomized controlled study had one intervention (mobile application) and one control (standard of care - spiral notebook) group. The study was approved by the first author's Institutional Review Board.
At each medical center, the obstetrics intake nurse serially screened new obstetrics patients for inclusion criteria from May to November 2015. If patients met inclusion criteria, the nurse invited the patient to talk to a research assistant about the study. Exclusion criteria included conditions that would elevate the patient's care to complicated obstetrics care (e.g., cardiovascular disease, diabetes mellitus, renal disorder, etc.). This was intended to capture a low-risk obstetrics patient population that would follow a standard 4-week pathway of care, in which patients attend a prenatal appointment once every four weeks during pregnancy.
The study used pre-assigned block randomization (each block n = 40) to balance the conditions throughout recruitment. Following consent and baseline measures, participants were randomized to the two conditions. Providers were blinded to patient participation in the study.
Surveys were completed at four prenatal appointments, 10-12 weeks, 28 weeks, 32 weeks, and 36 weeks gestation. All data collection was conducted with paper-and-pencil surveys in the clinic, immediately before and following each clinical appointment. At each appointment, patient weight and blood pressure were also recorded from the patient's electronic medical record.
At baseline, self-reported measures included demographics, health literacy, and patient activation. Health literacy was assessed using the self-reported Functional, Communicative, Critical Health Literacy Scale (Ishikawa, Takeuchi, \& Yano, 2008) Patient activation was assessed with the validated, licensed patient activation measure (PAM) (Greene \& Hibbard, 2012; Greene, Hibbard, Sacks, \& Overton, 2013; Hibbard, Mahoney, Stockard, \& Tusler, 2005; Hibbard et al., 2004), which uses 13 Likert-type items to create a continuous patient activation measure on a scale of 0 (not activated) to 100 (most activated). PAM was also replicated at time 4 (32 week appointment). As a surrogate measure, patient activation was also assessed at a behavioral level by asking patients at 36 weeks how many mobile apps they had used throughout their pregnancy.
Use was assessed with three measures. Before each appointment, patients completed two items regarding use of the education and engagement tool. First they indicated if they had brought the mobile app/notebook to the appointment with them (yes/no). Then, they reported how frequently they had used the tool over the past month 1) to look for information and 2) to record information (never = 0, once = 1, weekly = 4, or daily = 28).
Following each appointment, patients completed five subscales of the validated Prenatal Interpersonal Processes of Care (PIPC) scale (Wong et al., 2004), including elicitation/responsiveness to the patient, explanations of care, empowerment, patient-centered decision making, and emotional support. Responses to each item were transformed onto a 0 (negative perception) to 100 (positive perception) scale, and items are averaged to create subscales. Then subscales are averaged to calculate the overall PIPC scale.
At delivery, outcomes were recorded from the health record: gestational age, birth weight, and mode of delivery (vaginal or Caesarean section).
- Conditions
- Pregnancy
- Being tested
- Spiral notebook, Mobile application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiral notebookOther
Mobile applicationOther
| Study group | Role | What they receive |
|---|---|---|
| Communication modality: spiral notebook | Active comparator | Not described Receives: Other: Spiral notebook |
| Communication modality: mobile application | Experimental | Not described Receives: Other: Mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portability across time
Question if a patient brings tool to appointments and uses it between appointments
Measured: 16-20 weeks gestation, 28 weeks gestation, 32 weeks gestation, 36 weeks gestation
Patient activation across time
Patient activation, defined as the knowledge, skills, and confidence to self-manage health
Measured: 8-10 weeks gestation, 32 weeks gestation
Prenatal Interpersonal Processes of Care across time
Patient perception of the prenatal providers communicative behavior
Measured: 16-20 weeks gestation, 28 weeks gestation, 32 weeks gestation, 36 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start1 May 2015
- Primary completion30 Aug 2015
- Study completion31 Dec 2015
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 PregnancyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305003
- Sponsor's protocol ID
- FAM 81-3193
- Status last verified
- Oct 2017
- First submitted
- 26 Sep 2017
- Last updated
- 9 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ledford CJW, Canzona MR, Cafferty LA, Hodge JA. Mobile application as a prenatal education and engagement tool: A randomized controlled pilot. Patient Educ Couns. 2016 Apr;99(4):578-582. doi: 10.1016/j.pec.2015.11.006. Epub 2015 Nov 10.
PubMed 26610389Ledford CJW, Womack JJ, Rider HA, Seehusen AB, Conner SJ, Lauters RA, Hodge JA. Unexpected Effects of a System-Distributed Mobile Application in Maternity Care: A Randomized Controlled Trial. Health Educ Behav. 2018 Jun;45(3):323-330. doi: 10.1177/1090198117732110. Epub 2017 Sep 16.
PubMed 28918669
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating How a Mobile App Can Improve Prenatal Care: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03305003
- Acronym / sponsor ID
- FAM 81-3193
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 30 Aug 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 9 Oct 2017 (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.
Throughout the Military Health System, pregnant mothers are issued a spiral-bound guide that provides week by week information about pregnancy, preventive health messages, appointment information, and space to record their experiences throughout their pregnancy. When used accordingly, the evidence-based guide is an effective tool for motivating patients to participate in their own healthcare and achieve care goals. However, the spiral-bound paper modality results in patients forgetting the book for appointments or losing it. By testing a mobile application (app) from the current publication, the MHS leverages the efforts which created the guide while increasing patient and provider use.
The multisite testing (randomized controlled trial) of a mobile application developed from the current spiral-bound "Pregnancy and Childbirth: A Goal Oriented Guide to Prenatal Care" created by the VA and DoD provides an innovative, cost-effective opportunity to improve provider-patient communication and patient care.
Detailed description
The study was conducted in the women's health and family medicine departments of one community hospital and two medical centers across three states (Georgia, Nevada, and Virginia). In this hospital system, women are distributed a spiral notebook at their obstetric care intake appointment, which generally is scheduled for 8-10 weeks gestation. The spiral notebook is designed for two purposes: 1) patient education of what happens throughout pregnancy, and 2) patient record keeping of the patient's own pregnancy experience, including space for recording weight, blood pressure, and journaling about what they experience between prenatal appointments. The mobile app used in this study was designed for the same two purposes and contained identical content, though through a mobile design interface (available on both Android and iOS platforms). After the pilot study, patient feedback on the mobile app was used to create a beta version. Notable differences were a feature for users to change font size, a search function, and weekly reminders. No substantive content changed. This randomized controlled study had one intervention (mobile application) and one control (standard of care - spiral notebook) group. The study was approved by the first author's Institutional Review Board.
At each medical center, the obstetrics intake nurse serially screened new obstetrics patients for inclusion criteria from May to November 2015. If patients met inclusion criteria, the nurse invited the patient to talk to a research assistant about the study. Exclusion criteria included conditions that would elevate the patient's care to complicated obstetrics care (e.g., cardiovascular disease, diabetes mellitus, renal disorder, etc.). This was intended to capture a low-risk obstetrics patient population that would follow a standard 4-week pathway of care, in which patients attend a prenatal appointment once every four weeks during pregnancy.
The study used pre-assigned block randomization (each block n = 40) to balance the conditions throughout recruitment. Following consent and baseline measures, participants were randomized to the two conditions. Providers were blinded to patient participation in the study.
Surveys were completed at four prenatal appointments, 10-12 weeks, 28 weeks, 32 weeks, and 36 weeks gestation. All data collection was conducted with paper-and-pencil surveys in the clinic, immediately before and following each clinical appointment. At each appointment, patient weight and blood pressure were also recorded from the patient's electronic medical record.
At baseline, self-reported measures included demographics, health literacy, and patient activation. Health literacy was assessed using the self-reported Functional, Communicative, Critical Health Literacy Scale (Ishikawa, Takeuchi, \& Yano, 2008) Patient activation was assessed with the validated, licensed patient activation measure (PAM) (Greene \& Hibbard, 2012; Greene, Hibbard, Sacks, \& Overton, 2013; Hibbard, Mahoney, Stockard, \& Tusler, 2005; Hibbard et al., 2004), which uses 13 Likert-type items to create a continuous patient activation measure on a scale of 0 (not activated) to 100 (most activated). PAM was also replicated at time 4 (32 week appointment). As a surrogate measure, patient activation was also assessed at a behavioral level by asking patients at 36 weeks how many mobile apps they had used throughout their pregnancy.
Use was assessed with three measures. Before each appointment, patients completed two items regarding use of the education and engagement tool. First they indicated if they had brought the mobile app/notebook to the appointment with them (yes/no). Then, they reported how frequently they had used the tool over the past month 1) to look for information and 2) to record information (never = 0, once = 1, weekly = 4, or daily = 28).
Following each appointment, patients completed five subscales of the validated Prenatal Interpersonal Processes of Care (PIPC) scale (Wong et al., 2004), including elicitation/responsiveness to the patient, explanations of care, empowerment, patient-centered decision making, and emotional support. Responses to each item were transformed onto a 0 (negative perception) to 100 (positive perception) scale, and items are averaged to create subscales. Then subscales are averaged to calculate the overall PIPC scale.
At delivery, outcomes were recorded from the health record: gestational age, birth weight, and mode of delivery (vaginal or Caesarean section).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Communication modality: spiral notebook | Active comparator | Other: Spiral notebook |
| Communication modality: mobile application | Experimental | Other: Mobile application |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women (older than 18 years) who initiate obstetrics care (in the Women's Health or Family Health clinics) at the three sites.
Key exclusion criteria (23 listed)
- Exclusion criteria in this study follow the guidelines for patients who are escalated in obstetrical care, to include…
- Cardiovascular disease
- Cardiac abnormality
- Diabetes Mellitus - Type I or Type II
- Renal disorder
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 |
|---|---|---|
| Spiral notebook | Other | Communication modality: spiral notebook |
| Mobile application | Other | Communication modality: mobile application |
Primary outcome
Portability across time
Time frame: 16-20 weeks gestation, 28 weeks gestation, 32 weeks gestation, 36 weeks gestation
Question if a patient brings tool to appointments and uses it between appointments
Patient activation across time
Time frame: 8-10 weeks gestation, 32 weeks gestation
Patient activation, defined as the knowledge, skills, and confidence to self-manage health
Prenatal Interpersonal Processes of Care across time
Time frame: 16-20 weeks gestation, 28 weeks gestation, 32 weeks gestation, 36 weeks gestation
Patient perception of the prenatal providers communicative behavior
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 9 Oct 2017.
- Background: PubMed 26610389Ledford CJW, Canzona MR, Cafferty LA, Hodge JA. Mobile application as a prenatal education and engagement tool: A randomized controlled pilot. Patient Educ Couns. 2016 Apr;99(4):578-582. doi: 10.1016/j.pec.2015.11.006. Epub 2015 Nov 10.
- Results publication: PubMed 28918669Ledford CJW, Womack JJ, Rider HA, Seehusen AB, Conner SJ, Lauters RA, Hodge JA. Unexpected Effects of a System-Distributed Mobile Application in Maternity Care: A Randomized Controlled Trial. Health Educ Behav. 2018 Jun;45(3):323-330. doi: 10.1177/1090198117732110. Epub 2017 Sep 16.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Spiral notebook and Mobile application in people with Pregnancy, run by Henry M. Jackson Foundation for the Advancement of Military Medicine.
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 1 inclusion and 23 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 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Portability across time (time frame: 16-20 weeks gestation, 28 weeks gestation, 32 weeks gestation, 36 weeks gestation). The study lists 3 primary outcomes in all. 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 NCT03305003, 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 9 Oct 2017.