Intervention StudyPERTHNCT03088501
Participant Engagement and Retention Trial in a Public Hospital (PERTH): An RCT Protocol
A study testing Interactive voice response system and Mother and baby affairs workshop in people with Intervention Study, run by Public Health Foundation of India at 1 site in India.
Trial summary
MAASTHI (Maternal Antecedents of Adiposity Studying the Transgenerational role of Hyperglycaemia and Insulin) is a prospective birth cohort with the aim of assessing the effects of glucose levels in pregnancy on the risk of adverse infant outcomes, especially in predicting the possible risk markers of later chronic… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Intervention Study
- What is being tested?
- Interactive voice response system and Mother and baby affairs workshop
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteIndia
- Study dates
- 12 Jun 2018to 30 Dec 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women between 14 to 28 weeks of gestational age and those who plan to deliver in the study hospital and reside in the study location for the next five years. She must be able to speak Kannada, Hindi or English and should be willing to provide informed consent voluntarily. The participant must own or have sufficient access to a cell phone and should be able to operate a cell phone with a partner, relative, etc who stay with her.
Who cannot join
- Diabetes or Hepatitis B infection;
- HIV positivity;
- Pregnant women of other gestational ages
Trial locations and contacts
1 site in 1 country.
About this study
MAASTHI (Maternal Antecedents of Adiposity Studying the Transgenerational role of Hyperglycaemia and Insulin) is a prospective birth cohort with the aim of assessing the effects of glucose levels in pregnancy on the risk of adverse infant outcomes, especially in predicting the possible risk markers of later chronic diseases. The recruitment of the pregnant women in MAASTHI has begun in the month of April 2016. Of the eligible pregnant women only 77% completed the oral glucose tolerance tests.The follow ups of mother and child are conducted at birth and annually during the year 1, 2, 3 and 4 of the child. Despite stringent adherence of including only the residents of the source population, nearly 13% of the women were lost to follow-ups at birth. In order to prevent further loss to follow-ups in subsequent visits, the investigators aim to explore whether interventions involving innovative Interactive Voice Response System (IVRS) and conducting mother and baby workshops can improve in the number pf women undergoing lab tests and subsequent follow-ups.
Read the detailed description
Longitudinal cohort studies are important for the understanding of etiological mechanisms of underlying hypotheses. However, it is particularly challenging to sustain participation of subjects in follow up visits in birth cohorts, as the observation period spans over several years, making it vulnerable to lose tracking subjects for several reasons. These include change in location of residence and lack of interest in the later stages of the study. In India, the traditional practice of pregnant women leaving the study area to return to their maternal residence for delivery. Few groups belonging to ethnic minorities, with low family income or low education can be at higher risk of selective attrition. In the absence of high follow-up rate, the results from prospective cohort studies are can be biased. Such a bias can occur if the reason for the loss is related to the outcome under investigation. The cohort studies done in India have variable rates of loss to follow-up varying from, 14-82%. The barriers for retaining greater proportion of study participants can be due to several reasons. While a number of reviews have reported different ways of improving study participation, little is known about the effectiveness of specific retention strategies deployed in retention of mothers and infants in a birth cohort.
The proportion of pregnant women turning up for regular antenatal health checkups is poor in India. This is due to several reasons including lack of awareness, lack of social support, long waiting time, financial constraints and fear of hospital care. Evidence suggests that maternal education, husband's education, marital status, availability, cost, household income, women's employment, media exposure and previous obstetric history affects uptake of antenatal care services. According to National Family Health Survey (NFHS) (2014-15), only 55.5% of women in urban Bangalore had completed the required four antenatal care visits during pregnancy.
MAASTHI (Maternal Antecedents of Adiposity Studying the Transgenerational role of Hyperglycaemia and Insulin) is a prospective birth cohort with the aim of assessing the effects of glucose levels in pregnancy on the risk of adverse infant outcomes, especially in predicting the possible risk markers of later chronic diseases. The recruitment of the pregnant women in MAASTHI has begun in the month of April 2016. Of the eligible pregnant women only 77% completed the oral glucose tolerance tests despite offering the test free of cost and repeated reminders by the research team to get tested for gestational diabetes. After completion of OGTT, the follow ups of mother and child are conducted at birth and annually during the year 1, 2, 3 and 4 of the child. Despite stringent adherence of including only the residents of the source population, nearly 13% of the women were lost to follow-ups at birth. These women delivered in a different hospital mostly due to obstetric complications. Currently around 80 participants are recruited per month, with completion of all their records, anthropometry measurements, and Oral Glucose Tolerance Test (OGTT). Once the OGTT is done between 24-32 weeks of gestation, there is no further opportunity to meet them again till the delivery. The duration without contact increases the likelihood for attrition of future follow-ups. In the intervening period of initial contact and follow-up's, it is important that the research staff constantly engage with the participants through innovative methods. In order to improve the number of women undergoing OGTT and follow-ups, an intervention trial will be carried out that examines the role of innovative 1) IVR and 2)Mother and baby workshops during the intervening time period between baseline and follow-up.
- Conditions
- Intervention Study
- Being tested
- Interactive voice response system, Mother and baby affairs workshop
- Keywords
- Birth cohort, follow-up, IVRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive voice response systemBehavioural
IVR allows the pregnant women, their family members to interact with a computer system using a telephone.Through IVR, women receive a 2-3 minute call that reminds them of lab test, their next follow-up visit and also provides information on child care attendance, breastfeeding, introduction of solid foods, motor development, and sleep.
Mother and baby affairs workshopBehavioural
Mother and baby affairs workshop will involve antenatal workshop and counseling for parents. The intervention will involve brief talk by health professionals, quiz activities, role-plays on personal hygiene, nutritional food, institutional delivery, precautions at the time of delivery, caring for the baby, feeding of colostrum, homemade baby food, immunization, and family planning measures.
| Study group | Role | What they receive |
|---|---|---|
| Interactive Voice Response System | Experimental | Through IVRS, women will receive a 2-3 minute call that informs them about their lab test, next follow-up visit, breastfeeding, introduction of solid foods, immunization, motor development, and sleep. Receives: Behavioral: Interactive voice response system |
| Mother and Baby Affairs (MBA) workshops | Experimental | This will involve antenatal workshop and counselling for parents.
* Brief talk by health professionals.
* Role-plays Receives: Behavioral: Mother and baby affairs workshop |
| Control Arm | No intervention | The participants in this group do not get any specific interventions but would receive standard instructions to attend follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the proportion of participants visiting the hospital for OGTT before 32 weeks of gestation.
Successful follow-up assessment will be defined as completion of lab tests of mother within the designated time of 32 weeks of gestation. Response rate will be estimated as the number of women who complete lab tests done by research staff divided by the total number of women who completed 32 weeks of gestation. Loss to follow up rate will be measured as the number of women who missed lab tests divided by the total number of women who completed 32 weeks of gestation during the corresponding study time period in the study population. Time frame is calculated based on the start of the intervention at 22 week of gestation to the time when the mother's gestational age is 32 weeks, which is a total duration of 10 weeks.
Measured: 10 week
The proportion of participants who successfully complete follow-up assessment within one week of delivery
Those who successfully complete, follow-up assessment within one week of delivery. Successful follow-up assessment will be defined as completion of follow-up questionnaire and anthropometry within the designated time of one week from the date of delivery. Follow-up rate will be estimated as the numbers of follow ups done by research staff divided by the total number of eligible live births due in the corresponding time period in the study population. The loss to follow up rate will be measured as the number of missed follow-ups divided by the total number of eligible live births due in the corresponding time period in the study population. The time frame is calculated based on the start of the intervention at 22 weeks of gestation to 40 weeks at the time of delivery, which is the duration of 18 weeks.
Measured: 18 week
The proportion of participants who successfully complete second follow-up assessment when the infant is 3.5 month old.
Successful follow-up assessment will be defined as completion of follow-up questionnaire and anthropometry of mother and child within the designated time of 3.5 months ±15 days since the date of birth. Follow-up rate will be estimated as the number of 3.5 months follows ups done by research staff divided by the total number of 3.5-month-old infants during the corresponding study time period in the study population. The loss to follow up rate will be measured as the number of missed follow-ups divided by the total number of 3.5-months-old infants during the corresponding study time period in the study population. The time frame is calculated based on the start of the intervention at 22 weeks of gestation to the time when the infant is 3.5 months old(14 weeks) which is a total duration of 32 weeks.
Measured: 32 week
Secondary outcomes (1)
The secondary outcome involves cost-benefit analysis of the IVRS and MBA workshop
An economic evaluation of the intervention package in improving successive health visits compared to a control group will be done. A cost-effectiveness analysis will be done by assessing the balance between costs of the intervention and effects of improved visits from a healthcare provision perspective. Costs for all separate actions and time used by all individual healthcare professionals will be mapped including the costs towards the workshop program, costs for the IVRS and all other materials. The costs involved in the intervention package and the benefits achieved will be compared with those of control arm.Time frame: cost effective analysis will be done within 8 weeks after the 3.5 month follow-up.(32 week+8 week=40 week)
Measured: 40 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start12 Jun 2018
- Primary completion30 Jun 2019
- Study completion30 Dec 2019
Why it stopped: The PERTH RCT was nested within the MAASTHI birth cohort. PERTH study was stopped as MAASTHI has completed it's recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intervention StudyStudies 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
- Model description
- Participants will be randomized into each arm on a 1:1:1, using a computer-generated randomization list. Written allocation of assignments will be sealed in individual, sequentially numbered, non-resealable, opaque envelopes that will be used to allocate to the targeted number of participants.Once the participant is assigned to the arm, their unique respondent Identification Number ID(RID) and the arm to which they are allocated are recorded by the research assistants
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Foundation of India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088501
- Sponsor's protocol ID
- LN0182
- Acronym
- PERTH
- Status last verified
- Jan 2020
- First submitted
- 14 Dec 2016
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no drug or device being tested. This trial involves testing out the behavioural intervention in comparison with phone based technology for interactive voice based response to increase the follow-up of pregnant women.
Publications
Babu GR, Karthik M, Ravi D, Ana Y, Shriyan P, Hasige KK, Deshpande K, Siddlingaiah LB, Kinra S, Murthy GVS. What makes the pregnant women revisit public hospitals for research? Participant engagement and retention trial in a public hospital (PERTH): an RCT protocol. BMC Pregnancy Childbirth. 2018 Sep 12;18(1):369. doi: 10.1186/s12884-018-2000-1.
PubMed 30208868
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participant Engagement and Retention Trial in a Public Hospital (PERTH): An RCT Protocol
- ClinicalTrials.gov ID
- NCT03088501
- Acronym / sponsor ID
- PERTH / LN0182
- Conditions
- Intervention Study
- Keywords
- Birth cohort, follow-up, IVRS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PERTH RCT was nested within the MAASTHI birth cohort. PERTH study was stopped as MAASTHI has completed it's recruitment.
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Public Health Foundation of IndiaUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 23 Mar 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.
MAASTHI (Maternal Antecedents of Adiposity Studying the Transgenerational role of Hyperglycaemia and Insulin) is a prospective birth cohort with the aim of assessing the effects of glucose levels in pregnancy on the risk of adverse infant outcomes, especially in predicting the possible risk markers of later chronic diseases. The recruitment of the pregnant women in MAASTHI has begun in the month of April 2016. Of the eligible pregnant women only 77% completed the oral glucose tolerance tests.The follow ups of mother and child are conducted at birth and annually during the year 1, 2, 3 and 4 of the child. Despite stringent adherence of including only the residents of the source population, nearly 13% of the women were lost to follow-ups at birth. In order to prevent further loss to follow-ups in subsequent visits, the investigators aim to explore whether interventions involving innovative Interactive Voice Response System (IVRS) and conducting mother and baby workshops can improve in the number pf women undergoing lab tests and subsequent follow-ups.
Detailed description
Longitudinal cohort studies are important for the understanding of etiological mechanisms of underlying hypotheses. However, it is particularly challenging to sustain participation of subjects in follow up visits in birth cohorts, as the observation period spans over several years, making it vulnerable to lose tracking subjects for several reasons. These include change in location of residence and lack of interest in the later stages of the study. In India, the traditional practice of pregnant women leaving the study area to return to their maternal residence for delivery. Few groups belonging to ethnic minorities, with low family income or low education can be at higher risk of selective attrition. In the absence of high follow-up rate, the results from prospective cohort studies are can be biased. Such a bias can occur if the reason for the loss is related to the outcome under investigation. The cohort studies done in India have variable rates of loss to follow-up varying from, 14-82%. The barriers for retaining greater proportion of study participants can be due to several reasons. While a number of reviews have reported different ways of improving study participation, little is known about the effectiveness of specific retention strategies deployed in retention of mothers and infants in a birth cohort.
The proportion of pregnant women turning up for regular antenatal health checkups is poor in India. This is due to several reasons including lack of awareness, lack of social support, long waiting time, financial constraints and fear of hospital care. Evidence suggests that maternal education, husband's education, marital status, availability, cost, household income, women's employment, media exposure and previous obstetric history affects uptake of antenatal care services. According to National Family Health Survey (NFHS) (2014-15), only 55.5% of women in urban Bangalore had completed the required four antenatal care visits during pregnancy.
MAASTHI (Maternal Antecedents of Adiposity Studying the Transgenerational role of Hyperglycaemia and Insulin) is a prospective birth cohort with the aim of assessing the effects of glucose levels in pregnancy on the risk of adverse infant outcomes, especially in predicting the possible risk markers of later chronic diseases. The recruitment of the pregnant women in MAASTHI has begun in the month of April 2016. Of the eligible pregnant women only 77% completed the oral glucose tolerance tests despite offering the test free of cost and repeated reminders by the research team to get tested for gestational diabetes. After completion of OGTT, the follow ups of mother and child are conducted at birth and annually during the year 1, 2, 3 and 4 of the child. Despite stringent adherence of including only the residents of the source population, nearly 13% of the women were lost to follow-ups at birth. These women delivered in a different hospital mostly due to obstetric complications. Currently around 80 participants are recruited per month, with completion of all their records, anthropometry measurements, and Oral Glucose Tolerance Test (OGTT). Once the OGTT is done between 24-32 weeks of gestation, there is no further opportunity to meet them again till the delivery. The duration without contact increases the likelihood for attrition of future follow-ups. In the intervening period of initial contact and follow-up's, it is important that the research staff constantly engage with the participants through innovative methods. In order to improve the number of women undergoing OGTT and follow-ups, an intervention trial will be carried out that examines the role of innovative 1) IVR and 2)Mother and baby workshops during the intervening time period between baseline and follow-up.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized into each arm on a 1:1:1, using a computer-generated randomization list. Written allocation of assignments will be sealed in individual, sequentially numbered, non-resealable, opaque envelopes that will be used to allocate to the targeted number of participants.Once the participant is assigned to the arm, their unique respondent Identification Number ID(RID) and the arm to which they are allocated are recorded by the research assistants
| Arm | Type | Receives |
|---|---|---|
| Interactive Voice Response System | Experimental | Behavioral: Interactive voice response systemThrough IVRS, women will receive a 2-3 minute call that informs them about their lab test, next follow-up visit, breastfeeding, introduction of solid foods, immunization, motor development, and sleep. |
| Mother and Baby Affairs (MBA) workshops | Experimental | Behavioral: Mother and baby affairs workshopThis will involve antenatal workshop and counselling for parents. * Brief talk by health professionals. * Role-plays |
| Control Arm | No intervention | –The participants in this group do not get any specific interventions but would receive standard instructions to attend follow-up. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women between 14 to 28 weeks of gestational age and those who plan to deliver in the study hospital and reside in the study location for the next five years. She must be able to speak Kannada, Hindi or English and should be willing to provide informed consent voluntarily. The participant must own or have sufficient access to a cell phone and should be able to operate a cell phone with a partner, relative, etc who stay with her.
Key exclusion criteria (3 listed)
- Diabetes or Hepatitis B infection;
- HIV positivity;
- Pregnant women of other gestational ages
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 |
|---|---|---|
| Interactive voice response systemIVR allows the pregnant women, their family members to interact with a computer system using a telephone.Through IVR, women receive a 2-3 minute call that reminds them of lab test, their next follow-up visit and also provides information on child care attendance, breastfeeding, introduction of solid foods, motor development, and sleep. | Behavioural | Interactive Voice Response System |
| Mother and baby affairs workshopMother and baby affairs workshop will involve antenatal workshop and counseling for parents. The intervention will involve brief talk by health professionals, quiz activities, role-plays on personal hygiene, nutritional food, institutional delivery, precautions at the time of delivery, caring for the baby, feeding of colostrum, homemade baby food, immunization, and family planning measures. | Behavioural | Mother and Baby Affairs (MBA) workshops |
Primary outcome
The primary outcome is the proportion of participants visiting the hospital for OGTT before 32 weeks of gestation.
Time frame: 10 week
Successful follow-up assessment will be defined as completion of lab tests of mother within the designated time of 32 weeks of gestation. Response rate will be estimated as the number of women who complete lab tests done by research staff divided by the total number of women who completed 32 weeks of gestation. Loss to follow up rate will be measured as the number of women who missed lab tests divided by the total number of women who completed 32 weeks of gestation during the corresponding study time period in the study population. Time frame is calculated based on the start of the intervention at 22 week of gestation to the time when the mother's gestational age is 32 weeks, which is a total duration of 10 weeks.
The proportion of participants who successfully complete follow-up assessment within one week of delivery
Time frame: 18 week
Those who successfully complete, follow-up assessment within one week of delivery. Successful follow-up assessment will be defined as completion of follow-up questionnaire and anthropometry within the designated time of one week from the date of delivery. Follow-up rate will be estimated as the numbers of follow ups done by research staff divided by the total number of eligible live births due in the corresponding time period in the study population. The loss to follow up rate will be measured as the number of missed follow-ups divided by the total number of eligible live births due in the corresponding time period in the study population. The time frame is calculated based on the start of the intervention at 22 weeks of gestation to 40 weeks at the time of delivery, which is the duration of 18 weeks.
The proportion of participants who successfully complete second follow-up assessment when the infant is 3.5 month old.
Time frame: 32 week
Successful follow-up assessment will be defined as completion of follow-up questionnaire and anthropometry of mother and child within the designated time of 3.5 months ±15 days since the date of birth. Follow-up rate will be estimated as the number of 3.5 months follows ups done by research staff divided by the total number of 3.5-month-old infants during the corresponding study time period in the study population. The loss to follow up rate will be measured as the number of missed follow-ups divided by the total number of 3.5-months-old infants during the corresponding study time period in the study population. The time frame is calculated based on the start of the intervention at 22 weeks of gestation to the time when the infant is 3.5 months old(14 weeks) which is a total duration of 32 weeks.
1 secondary outcome
The secondary outcome involves cost-benefit analysis of the IVRS and MBA workshop
Time frame: 40 week
Results and safety
The study was stopped early (reason given: The PERTH RCT was nested within the MAASTHI birth cohort. PERTH study was stopped as MAASTHI has completed it's recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 30208868Babu GR, Karthik M, Ravi D, Ana Y, Shriyan P, Hasige KK, Deshpande K, Siddlingaiah LB, Kinra S, Murthy GVS. What makes the pregnant women revisit public hospitals for research? Participant engagement and retention trial in a public hospital (PERTH): an RCT protocol. BMC Pregnancy Childbirth. 2018 Sep 12;18(1):369. doi: 10.1186/s12884-018-2000-1.
- Individual participant dataSharing planned: No. There is no drug or device being tested. This trial involves testing out the behavioural intervention in comparison with phone based technology for interactive voice based response to increase the follow-up of pregnant women.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive voice response system and Mother and baby affairs workshop in people with Intervention Study, run by Public Health Foundation of India at 1 site in India.
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 3 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: stopped early, as of the sponsor's last update on 18 Jan 2020. 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 India. 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 was stopped early (reason given: The PERTH RCT was nested within the MAASTHI birth cohort. PERTH study was stopped as MAASTHI has completed it's recruitment.). Results are not available in the source record.
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?
The primary outcome is the proportion of participants visiting the hospital for OGTT before 32 weeks of gestation. (time frame: 10 week). 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 NCT03088501, which also lists 1 linked publication.
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 18 Jan 2020.