| CTRI Number |
CTRI/2024/07/070142 [Registered on: 07/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effectiveness of utilizing village health nurses to promote the post-delivery follow up testing of women who have gestational diabetes |
|
Scientific Title of Study
|
Awareness Generation through Village Health Nurses as
Advocates for Long-term Follow up of Women with Gestational Diabetes
Mellitus (AVAL-GDM): A Cluster Randomized Controlled Trial |
| Trial Acronym |
AVAL -GDM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DPHPM/IEC/014/V3 Date 16-05-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr T S Selvavinayagam |
| Designation |
Director |
| Affiliation |
Directorate of Public Health and Preventive Medicine |
| Address |
Directorate of Public Health and Preventive Medicine,
No. 359, Anna Salai, DMS Campus, Teynamepet, Chennai- 600006
Chennai
TAMIL NADU
600006
India |
| Phone |
9445030714 |
| Fax |
|
| Email |
drsvinayagam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T S Selvavinayagam |
| Designation |
Director |
| Affiliation |
Directorate of Public Health and Preventive Medicine |
| Address |
Directorate of Public Health and Preventive Medicine,
No. 359, Anna Salai, DMS Campus, Teynamepet, Chennai- 600006
Chennai
TAMIL NADU
600006
India |
| Phone |
9445030714 |
| Fax |
|
| Email |
drsvinayagam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T S Selvavinayagam |
| Designation |
Director |
| Affiliation |
Directorate of Public Health and Preventive Medicine |
| Address |
Directorate of Public Health and Preventive Medicine,
No. 359, Anna Salai, DMS Campus, Teynamepet, Chennai- 600006
Chennai
TAMIL NADU
600006
India |
| Phone |
9445030714 |
| Fax |
|
| Email |
drsvinayagam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Directorate of Public Health and Preventive Medicine. 359, Anna Salai, DMS Campus, Teynampet,, Chennai - 600006 |
|
|
Primary Sponsor
|
| Name |
Dr T S Selvavinayagam |
| Address |
Directorate of Public Health and Preventive Medicine.359, Anna Salai, DMS Campus, Teynampet,, Chennai - 600006 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr T S Selvavinayagam |
Directorate of Public Health and Preventive Medicine |
Room no 1, 5th floor, 359, Anna Salai, DMS Campus, Teynampet, Chennai - 600006 (Recruitment site)
Chennai
TAMIL NADU |
9445030714
drsvinayagam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Directorate of Public Health and Preventive Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O244||Gestational diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Educational materials on GDM and postpartum follow up |
The control arm will receive educational pamphlets providing general guidelines on postpartum care for women with GDM. These materials will offer an overview of the long-term health implications of GDM for both mother and child. The VHNs and women with GDM can utilise these educational pamphlets at any point of time throughout the duration of the study period. The frequency and duration of using these educational pamphlets will vary considerably depending on the level of engagement of VHNs and women with GDM in the control arm. The duration of follow up is 24 months. |
| Intervention |
Training for VHNs |
The intervention arm will receive a structured training program in the form of a 2-day (4-6 hr/ day) workshop to the selected VHNs from each PHC. The training will be conducted in four small batches, each comprising 17 VHNs. Leveraging collaborative, interactive, and participative methods, the training sessions will actively engage participants. Interactive discussions, case studies, and role-play scenarios will foster a deeper understanding and application of learned concepts Through the introduction of the mHealth application, VHNs will receive prompts to remind women with GDM of follow-up appointments at 6-12 weeks, 6 months, 1 year and 2 years post partum. For the women with GDM the mHealth interface offers timely reminders for post partum testing and access to educational materials. The intervention consists of onsite and offsite training components. There will be 3 onsite training sessions for the VHNs. The first onsite training for VHNs is a 2-day workshop that will be approximately 12 hours (6 hours/day). The second and third refresher training sessions will be approximately for 4 hours each. Therefore, the total onsite training duration for VHNs in the intervention arm is 20 hours. The 1st onsite training for VHNs will take place in the 7th month while the 2nd and 3rd refresher training will take place in the 16th and 25th month respectively. Offsite training components for VHNs in the intervention arm will include educational pamphlets and mHealth application. mHealth application will contain refresher quizzes which will be utilised by VHNs in the intervention group at 4 different time points ( 6-12 weeks, 6 months, 1 year and 2 years). The application will also contain learning materials which can be accessed by the VHNs and women with GDM in the intervention group at any given period of time throughout the duration of the trial. As such the frequency and duration of such activities will show considerable variability depending on the level of engagement of the VHNs and women with GDM. The duration of intervention is 24 months.
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1) Diagnosis of GDM in the current pregnancy confirmed by a 2-hour, 75-gram Oral Glucose Tolerance Test (OGTT) with a cut-off of greater than or equal to 140 mg/dL.
2) Women with GDM at 28 weeks of gestation and beyond, OR those nearing delivery, OR those who have delivered and are within the 6-week postpartum period. |
|
| ExclusionCriteria |
| Details |
1) Presence of any physical or mental disabilities.
2) Presence of any chronic severe illnesses that can hinder the adoption of self-management or behaviour change practices advocated by our study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of women with GDM who undergo postpartum follow up and continuum of care.
|
6-12 weeks, 6 months, 1 year and 2 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Feasibility, acceptability, scalability, and sustainability of the intervention |
2 years |
| Health beliefs in terms of perceived susceptibility, severity, perceived barriers, facilitators and cues to action for postpartum continuum of care for women with GDM |
6-12 weeks, 6 months, 1 year and 2 years
|
Knowledge and practices of the VHNs related to postpartum
continuum of care for women with GDM |
6-12 weeks, 6 months, 1 year and 2 years |
|
|
Target Sample Size
|
Total Sample Size="700"
Sample Size from India="700"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsvinayagam@gmail.com].
- For how long will this data be available start date provided 15-10-2027 and end date provided 06-12-2300?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a cluster randomized controlled trial which compares the proportion of women with Gestational Diabetes Mellitus (GDM) who undergo postpartum follow up in both the intervention and the control arms. The intervention group consists of trained Village Health Nurses (VHNs) who receive access to the intervention toolkit and mHealth application to persuade women with GDM to come for postpartum follow up while VHNs in the control arm provide routine antenatal and postpartum care according to the existing government policies. It is hypothesized that VHNs sensitized on long term complications of GDM and the implications of postpartum care will be more successful in facilitating women with GDM to undergo periodic assessment of their glycemic status postpartum. In this study, the unit of intervention are the Village Health Nurses and the unit of outcome assessment are the women with Gestational Diabetes Mellitus. |