Pregnancy
Conditions
Keywords
medical record, pregnancy, Internet
Brief 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. 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
Interventions
BEHAVIORALpersonalized web prenatal information
BEHAVIORALgeneral web prenatal information
Sponsors
McMaster University
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* less than 28 weeks pregnant access to Internet
Exclusion criteria
* cannot speak/read English and no translator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Information Easy to Understand | 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. |
| Uptake of Service | 11 months | Number of log-ins |
| Easy to Log on | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Personalized Information and Internet Access Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team. | 97 |
| General Resource Internet Access Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team | 96 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not complete survey | 22 | 43 |
| Overall Study | Lost to Follow-up | 7 | 7 |
| Overall Study | Miscarriage | 5 | 3 |
Baseline characteristics
| Characteristic | Personalized Information and Internet Access | General Resource Internet Access | Total |
|---|---|---|---|
| Age, Continuous | 27.7 years STANDARD_DEVIATION 5.3 | 26.4 years STANDARD_DEVIATION 5.6 | 27.1 years STANDARD_DEVIATION 5.5 |
| At least some post-secondary education | 58 Participants | 59 Participants | 117 Participants |
| Married or common-law | 75 Participants | 72 Participants | 147 Participants |
| Primiparous | 60 Participants | 64 Participants | 124 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 97 Participants | 96 Participants | 193 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 96 |
| other Total, other adverse events | 0 / 97 | 0 / 96 |
| serious Total, serious adverse events | 0 / 97 | 0 / 96 |
Outcome results
Primary
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.
Time frame: 11 months
Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personalized Information and Internet Access | Easy to Find Information | 1.9 score on a scale | Standard Deviation 0.9 |
| General Resource Internet Access | Easy to Find Information | 1.8 score on a scale | Standard Deviation 0.7 |
p-value: 0.57t-test, 2 sided
Primary
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.
Time frame: 11 months
Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personalized Information and Internet Access | Easy to Log on | 1.4 score on a scale | Standard Deviation 0.5 |
| General Resource Internet Access | Easy to Log on | 1.5 score on a scale | Standard Deviation 0.9 |
p-value: 0.84t-test, 2 sided
Primary
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.
Time frame: 11 months
Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personalized Information and Internet Access | Helped me Learn About Risks | 1.9 score on a scale | Standard Deviation 0.8 |
| General Resource Internet Access | Helped me Learn About Risks | 1.8 score on a scale | Standard Deviation 0.8 |
p-value: 0.46t-test, 2 sided
Primary
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.
Time frame: 11 months
Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personalized Information and Internet Access | Helped me Make Decisions | 2.1 score on a scale | Standard Deviation 0.9 |
| General Resource Internet Access | Helped me Make Decisions | 2.4 score on a scale | Standard Deviation 1.2 |
p-value: 0.26t-test, 2 sided
Primary
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.
Time frame: 11 months
Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personalized Information and Internet Access | Helped me Remember Appointments | 2.9 score on a scale | Standard Deviation 1.3 |
| General Resource Internet Access | Helped me Remember Appointments | 3.5 score on a scale | Standard Deviation 1.4 |
p-value: 0.12t-test, 2 sided
Primary
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.
Time frame: 11 months
Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personalized Information and Internet Access | Helped me Stay Healthy | 1.8 score on a scale | Standard Deviation 0.8 |
| General Resource Internet Access | Helped me Stay Healthy | 1.6 score on a scale | Standard Deviation 0.7 |
p-value: 0.17t-test, 2 sided
Primary
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.
Time frame: 11 months
Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personalized Information and Internet Access | Helped me Understand Tests | 1.7 score on a scale | Standard Deviation 0.7 |
| General Resource Internet Access | Helped me Understand Tests | 1.6 score on a scale | Standard Deviation 0.8 |
p-value: 0.57t-test, 2 sided
Primary
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.
Time frame: 11 months
Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personalized Information and Internet Access | Information Easy to Understand | 1.4 score on a scale | Standard Deviation 0.5 |
| General Resource Internet Access | Information Easy to Understand | 1.5 score on a scale | Standard Deviation 0.6 |
p-value: 0.68t-test, 2 sided
Primary
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.
Time frame: 11 months
Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personalized Information and Internet Access | Learned Something New | 1.8 score on a scale | Standard Deviation 0.9 |
| General Resource Internet Access | Learned Something New | 1.9 score on a scale | Standard Deviation 0.8 |
p-value: 0.67t-test, 2 sided
Primary
Uptake of Service
Number of log-ins
Time frame: 11 months
Population: An intention-to-treat analysis was conducted. Participants were included in the analysis that started or completed the survey and excludes participants that were lost to follow-up or had a miscarriage.Intervention group: 63 completed survey + 22 partially complete survey =85). Control group: 53 completed survey + 43 partially complete survey = 96).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personalized Information and Internet Access | Uptake of Service | 10.4 Log-ins | Standard Deviation 17.8 |
| General Resource Internet Access | Uptake of Service | 1.8 Log-ins | Standard Deviation 1.4 |
p-value: <0.0001t-test, 2 sided