Participant Engagement and Retention Trial in a Public Hospital (PERTH): An RCT Protocol

NCT03088501 | Terminated

• 1 other identifier: LN0182
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Intervention Study

Keywords

Birth cohort, follow-up, IVRS

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  32 week

Secondary Outcomes (1)

• The secondary outcome involves cost-benefit analysis of the IVRS and MBA workshop

  40 week

Study Arms (3)

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.

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

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.

Interventions

Interactive voice response system BEHAVIORAL

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.

Interactive Voice Response System

Mother and baby affairs workshop BEHAVIORAL

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.

Mother and Baby Affairs (MBA) workshops

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Public Health Foundation of India: lead

Study Sites (1)

Sri rampura Referral Hospital

Bengaluru, Karnataka, 560021, India

Location

Related Publications (1)

• 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.

  PMID: 30208868 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: After meeting inclusion criteria, consenting to participate and completing a baseline questionnaire, participants will be immediately assigned to the randomized study arm by the RA who will open one of the sequentially numbered envelopes to determine allocation. Before opening the envelope, the Respondent ID number will be written on the envelope. The assignment schedule will be kept in a locked filing cabinet in the study coordinator's office at the Indian Institute of Public Health. Research staff and pregnant women cannot be blinded because the intervention requires their participation; however, the data analyst will be blinded to the study arm assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: March 23, 2017
• Study Start: June 12, 2018
• Primary Completion: June 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)