Clinical trial NCT03088501: Participant Engagement and Retention Trial in a Public Hospital (PERTH): An RCT Protocol
Official title: Participant Engagement and Retention Trial in a Public Hospital (PERTH): An RCT Protocol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intervention Study
Keywords: Birth cohort, follow-up, IVRS
Lead sponsor: Public Health Foundation of India
Sponsor class: OTHER
First posted: 2017-03-23
Enrollment: 171
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

* Diabetes or Hepatitis B infection;
* HIV positivity;
* Pregnant women of other gestational ages

Primary outcomes:
measure: The primary outcome is the proportion of participants visiting the hospital for OGTT before 32 weeks of gestation.
timeFrame: 10 week
measure: The proportion of participants who successfully complete follow-up assessment within one week of delivery
timeFrame: 18 week
measure: The proportion of participants who successfully complete second follow-up assessment when the infant is 3.5 month old.
timeFrame: 32 week
Secondary outcomes:
measure: The secondary outcome involves cost-benefit analysis of the IVRS and MBA workshop
timeFrame: 40 week
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: Sri rampura Referral Hospital
state: Karnataka
Study officials:
References:
citation: 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.