PregnancyNCT00182325
Effects of a Personalized Web-based Antenatal Care Planner
A study testing personalized web prenatal information and general web prenatal information in people with Pregnancy, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Many women are turning to the Internet to meet their health information needs, but the large amount of information available, as well as the unknown reliability and applicability of information can be overwhelming. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- personalized web prenatal information and general web prenatal information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2004to Sep 2006
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- less than 28 weeks pregnant access to Internet
Who cannot join
- cannot speak/read English and no translator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Women's Web Access to Their Own Antenatal Health Record and Personalized Health Information: Effect on Pregnancy Health Outcomes and Patient Satisfaction
Many women are turning to the Internet to meet their health information needs, but the large amount of information available, as well as the unknown reliability and applicability of information can be overwhelming. Studies in specific patient populations have determined that patients given access to personalized, on-line medical information are more satisfied with their care than patients provided generalized information. None of these studies have looked at whether this type of patient education would be helpful for pregnant women. This study is being done to determine whether pregnant women who have access to their own health records and personalized health information over the Internet are more satisfied with their prenatal care, and if they are more compliant with health visits and tests, compared to pregnant women who receive only generic pregnancy information on the Internet and from pamphlets
Read the detailed description
Many women are turning to the Internet to meet their health information needs, but the large amount of information available, as well as the unknown reliability and applicability of information can be overwhelming. Studies in specific patient populations have determined that patients given access to personalized, on-line medical information are more satisfied with their care than patients provided generalized information. None of these studies have looked at whether this type of patient education would be helpful for pregnant women. This study is being done to determine whether pregnant women who have access to their own health records and personalized health information over the Internet are more satisfied with their prenatal care, and if they are more compliant with health visits and tests, compared to pregnant women who receive only generic pregnancy information on the Internet and from pamphlets
Women are being randomly assigned to receive secure access to pregnancy health information links chosen by the centre's physicians, or to receive these links with access to their online personal health that includes the antenatal record and a section of their care planner, from the centre's electronic medical record
- Conditions
- Pregnancy
- Being tested
- personalized web prenatal information, general web prenatal information
- Keywords
- medical record, pregnancy, Internet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized web prenatal informationBehavioural
general web prenatal informationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| personalized web prenatal information | Experimental | Personalized health information for pregnancy through personal health record Receives: Behavioral: personalized web prenatal information |
| general web prenatal information | Active comparator | General pregnancy health related websites Receives: Behavioral: general web prenatal information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of Service
Number of log-ins
Measured: 11 months
Easy to Log on
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Measured: 11 months
Information Easy to Understand
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Measured: 11 months
Learned Something New
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Measured: 11 months
Easy to Find Information
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Measured: 11 months
Helped me Stay Healthy
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Measured: 11 months
Helped me Learn About Risks
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Measured: 11 months
Helped me Understand Tests
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Measured: 11 months
Helped me Make Decisions
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Measured: 11 months
Helped me Remember Appointments
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionAug 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor
- Investigators
- Heather Waters, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182325
- Sponsor's protocol ID
- RDF-160
- Status last verified
- Mar 2019
- First submitted
- 13 Sep 2005
- Last updated
- 10 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Web Access to Their Own Antenatal Health Record and Personalized Health Information: Effect on Pregnancy Health Outcomes and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT00182325
- Acronym / sponsor ID
- RDF-160
- Conditions
- Pregnancy
- Keywords
- medical record, pregnancy, Internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Feb 2004 (actual)
- Primary completion
- Aug 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 10 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many women are turning to the Internet to meet their health information needs, but the large amount of information available, as well as the unknown reliability and applicability of information can be overwhelming. Studies in specific patient populations have determined that patients given access to personalized, on-line medical information are more satisfied with their care than patients provided generalized information. None of these studies have looked at whether this type of patient education would be helpful for pregnant women. This study is being done to determine whether pregnant women who have access to their own health records and personalized health information over the Internet are more satisfied with their prenatal care, and if they are more compliant with health visits and tests, compared to pregnant women who receive only generic pregnancy information on the Internet and from pamphlets
Detailed description
Many women are turning to the Internet to meet their health information needs, but the large amount of information available, as well as the unknown reliability and applicability of information can be overwhelming. Studies in specific patient populations have determined that patients given access to personalized, on-line medical information are more satisfied with their care than patients provided generalized information. None of these studies have looked at whether this type of patient education would be helpful for pregnant women. This study is being done to determine whether pregnant women who have access to their own health records and personalized health information over the Internet are more satisfied with their prenatal care, and if they are more compliant with health visits and tests, compared to pregnant women who receive only generic pregnancy information on the Internet and from pamphlets
Women are being randomly assigned to receive secure access to pregnancy health information links chosen by the centre's physicians, or to receive these links with access to their online personal health that includes the antenatal record and a section of their care planner, from the centre's electronic medical record
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| personalized web prenatal information | Experimental | Behavioral: personalized web prenatal informationPersonalized health information for pregnancy through personal health record |
| general web prenatal information | Active comparator | Behavioral: general web prenatal informationGeneral pregnancy health related websites |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- less than 28 weeks pregnant access to Internet
Key exclusion criteria (1 listed)
- cannot speak/read English and no translator
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 |
|---|---|---|
| personalized web prenatal information | Behavioural | personalized web prenatal information |
| general web prenatal information | Behavioural | general web prenatal information |
Primary outcome
Uptake of Service
Time frame: 11 months
Number of log-ins
Easy to Log on
Time frame: 11 months
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Information Easy to Understand
Time frame: 11 months
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Learned Something New
Time frame: 11 months
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Easy to Find Information
Time frame: 11 months
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Helped me Stay Healthy
Time frame: 11 months
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Helped me Learn About Risks
Time frame: 11 months
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Helped me Understand Tests
Time frame: 11 months
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Helped me Make Decisions
Time frame: 11 months
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Helped me Remember Appointments
Time frame: 11 months
Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Heather Waters, MD principal investigator
McMaster 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 personalized web prenatal information and general web prenatal information in people with Pregnancy, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 1 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 10 Jun 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 Canada. 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?
Yes. Results are posted in the registry (first posted 10 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Uptake of Service (time frame: 11 months). The study lists 10 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 10 Jun 2019.