Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06277258
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2022-12-15
Brief Title:
Patient Empowerment in the Management of Gestational Diabetes Mellitus
Sponsor:
Public Health Foundation of Bangladesh
Organization:
Public Health Foundation of Bangladesh
Study Overview
Official Title:
Outcome of Patient Empowerment in the Management of Gestational Diabetes Mellitus A Clustered Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a clustered randomized controlled trial assessing the outcome of Patient Empowerment in the management of Gestational Diabetes Mellitus by applying the patient empowering model in the intervention group and the conventional method of treatment in the control group It will be conducted in four centres in Dhaka city of Bangladesh The primary outcome measures will be determining the frequency of good fetomaternal and neonatal outcome through glycemic control Target of Glycemic Status For Pregnant Mother Fasting 95 mgdL 53 mmolL Two-hour postprandial120 mgdL 67 mmolL For Neonate glycemic status at or above 25 mmoll Maternal outcome during pregnancy - Decrease chance of antenatal infections that is Vulvovaginitis and recurrent UTI Decrease pre-eclampsia Decrease Antepartum Hemorrhage and Polyhydramnios Maternal outcome in the form of mode of safe delivery- Increase frequency of vaginal delivery Decrease chance of obstructed labour Maternal outcome after delivery- Decrease chance of Postpartum Hemorrhage Decrease chance of puerperal sepsis Fetal Outcome- Less chance of Intra uterine death and prematurity Neonatal Outcome- Less chance of Birth injury Birth asphyxia Perinatal death Good Apgar score 7 in 1st and 5th minute Less need for NICU care and Less chance of macrosomia 4 kg at term Fewer proportion of patients will require insulin to manage GDM The secondary outcomes will be patient satisfaction and the patient will be a future resource person
Detailed Description:
Procedure of Study Including methods of intervention measurement estimation etc
Screen positive GDM patients will be recruited according to inclusion and exclusion criteria After taking consent they will be registered for study purpose According to computer generated randomization the health centres will be allocated and single method of management either patient empowerment or conventional method will be adopted for the whole cluster of the respective health centre The intervention group will only receive the Patient Empowerment package
The patients of intervention group along with antenatal check-up will go through the first session of the empowerment package on the first day of recruitment Then they will be evaluated through structured questions to know their level of perception understanding and retention about the diabetes and its management Those who will perform to get at least 80 out of 100 will be recognized as empowered Who fail to achieve that they will be called for next seating Patients unwilling to go through the process or failed to achieve the targeted score within three seating will be excluded Those who fulfilled the target they will be advised to follow the calorie and diet distribution schedule They will be advised to return back 2 days later with the blood sugar chart 6 times per day by SMBG Self-monitoring of blood glucose The respondents will get the materials like measuring cup hand manuals on diabetes glucometer and chart for record keeping
After evaluating the sugar chart if they are found poor performer they will be counselled and trained further and will have to come back again after two days At the same time patients satisfaction will be assessed with LIKERT scale Frequency of further visit will depend on patients performance
All the respondents from both groups are supposed to come for ANC at least at monthly interval initially up to 28 weeks and then fortnightly up to 36 weeks and then weekly up to delivery frequency of the visit may be more if necessary For Conventional non- intervention group at least 2 to 3 times blood sugar level should be checked within the follow up period Then all the pertinent variables will be recorded analyzed as per study objective and outcome to evaluate the effectiveness of patient empowerment in the management of GDM
Blood sample collection
Patients of GDM will be trained to measure their own blood sugar level both fasting and 2 hours postprandial by Glucometer at home and to maintain a blood sugar chart
Laboratory methods
In this study design apart from routine antenatal screening tests no other additional laboratory investigation will be done unless be otherwise needed on medical ground
Follow up of the patients
Both the study group and comparison group will be followed up as per study protocol at monthly interval initially up to 28 weeks and then fortnightly up to 36 weeks and then weekly up to delivery frequency of the visit may be more if necessary
Data Collection Tools
Pre-tested semi structured questionnaireinterview schedule and checklist
Data Collection Procedure
GDM cases will be enrolled in this study with taking written consent on the consent form Data will be collected by multiple techniques like face to face interview records findings of physical examination and observation information on concerned variables and will be documented Among the variables the fasting blood sugar and 2 hours after ingestion of 75-gram glucose will be considered as baseline for detection of GDM as screening test between 14 to 34 weeks of gestation Patient empowerment
All the clinical and investigative findings and therapeutic variables will be documented during each antenatal visit The ANC and its frequency should be according to conventional schedule Monthly up to 28 weeks fortnightly up to 36 weeks and then weekly up to delivery in low risk cases and for high risk the frequency of visit will be more In both the groups from patients blood sugar chart average blood sugar value will be documented monthly Each patient will be followed up to the end of puerperium that is 6 weeks after delivery
From each institute data will be collected with separate registration name and number and will be stored separately
Statistical analysis
The data will be analyzed according to cluster randomized trial protocol and all statistical analysis will be based on Intention to Treat ITT approach Descriptive statistics will be generated for all base line and follow-up data frequency and relative frequency for categorical data means with standard deviations SDs or 95 confidence intervals CIs for normally distributed continuous data and for non-normal data median and interquartile ranges
Univariable associations between baseline patient characteristics and outcome will be assessed using univariable Cox regression All statistically significant predictors will be assessed for possible confounding Potential confounders measured at baseline will be selected based on a directed acyclic graph DAG and univariate association finding Tests based on Schoenfeld residuals will be used to identify violations of the proportional hazards assumption Impact of intervention on for primary outcome adverse pregnancy outcome will be assessed using multilevel cox proportional hazard regression adjusting for plausible confounders Multilevel modelling will include a shared frailty term in the model to account for hospital-level clustering The between-group differences will be assessed enabling simultaneous examination of cluster and individual-level influences on outcomes Adjustment of the result for between-cluster variation will thus be achieved The effects of the intervention on maternal and neonatal outcomes and changes in physical activity and diet will be analysed by using generalized linear latent and mixed models and multilevel mixed-effects linear regression by fitting random effects models All analysis will be performed in Stata SE version 17
Quality assurance strategy
From research team PI Co-PI and other investigators and local GOB health managers will work together for effective implementation monitoring and evaluation of interventions They will jointly monitor the progress and oversee any deviation from the protocol
Screen positive GDM patients will be recruited according to inclusion and exclusion criteria After taking consent they will be registered for study purpose According to computer generated randomization the health centres will be allocated and single method of management either patient empowerment or conventional method will be adopted for the whole cluster of the respective health centre The intervention group will only receive the Patient Empowerment package
The patients of intervention group along with antenatal check-up will go through the first session of the empowerment package on the first day of recruitment Then they will be evaluated through structured questions to know their level of perception understanding and retention about the diabetes and its management Those who will perform to get at least 80 out of 100 will be recognized as empowered Who fail to achieve that they will be called for next seating Patients unwilling to go through the process or failed to achieve the targeted score within three seating will be excluded Those who fulfilled the target they will be advised to follow the calorie and diet distribution schedule They will be advised to return back 2 days later with the blood sugar chart 6 times per day by SMBG Self-monitoring of blood glucose The respondents will get the materials like measuring cup hand manuals on diabetes glucometer and chart for record keeping
After evaluating the sugar chart if they are found poor performer they will be counselled and trained further and will have to come back again after two days At the same time patients satisfaction will be assessed with LIKERT scale Frequency of further visit will depend on patients performance
All the respondents from both groups are supposed to come for ANC at least at monthly interval initially up to 28 weeks and then fortnightly up to 36 weeks and then weekly up to delivery frequency of the visit may be more if necessary For Conventional non- intervention group at least 2 to 3 times blood sugar level should be checked within the follow up period Then all the pertinent variables will be recorded analyzed as per study objective and outcome to evaluate the effectiveness of patient empowerment in the management of GDM
Blood sample collection
Patients of GDM will be trained to measure their own blood sugar level both fasting and 2 hours postprandial by Glucometer at home and to maintain a blood sugar chart
Laboratory methods
In this study design apart from routine antenatal screening tests no other additional laboratory investigation will be done unless be otherwise needed on medical ground
Follow up of the patients
Both the study group and comparison group will be followed up as per study protocol at monthly interval initially up to 28 weeks and then fortnightly up to 36 weeks and then weekly up to delivery frequency of the visit may be more if necessary
Data Collection Tools
Pre-tested semi structured questionnaireinterview schedule and checklist
Data Collection Procedure
GDM cases will be enrolled in this study with taking written consent on the consent form Data will be collected by multiple techniques like face to face interview records findings of physical examination and observation information on concerned variables and will be documented Among the variables the fasting blood sugar and 2 hours after ingestion of 75-gram glucose will be considered as baseline for detection of GDM as screening test between 14 to 34 weeks of gestation Patient empowerment
All the clinical and investigative findings and therapeutic variables will be documented during each antenatal visit The ANC and its frequency should be according to conventional schedule Monthly up to 28 weeks fortnightly up to 36 weeks and then weekly up to delivery in low risk cases and for high risk the frequency of visit will be more In both the groups from patients blood sugar chart average blood sugar value will be documented monthly Each patient will be followed up to the end of puerperium that is 6 weeks after delivery
From each institute data will be collected with separate registration name and number and will be stored separately
Statistical analysis
The data will be analyzed according to cluster randomized trial protocol and all statistical analysis will be based on Intention to Treat ITT approach Descriptive statistics will be generated for all base line and follow-up data frequency and relative frequency for categorical data means with standard deviations SDs or 95 confidence intervals CIs for normally distributed continuous data and for non-normal data median and interquartile ranges
Univariable associations between baseline patient characteristics and outcome will be assessed using univariable Cox regression All statistically significant predictors will be assessed for possible confounding Potential confounders measured at baseline will be selected based on a directed acyclic graph DAG and univariate association finding Tests based on Schoenfeld residuals will be used to identify violations of the proportional hazards assumption Impact of intervention on for primary outcome adverse pregnancy outcome will be assessed using multilevel cox proportional hazard regression adjusting for plausible confounders Multilevel modelling will include a shared frailty term in the model to account for hospital-level clustering The between-group differences will be assessed enabling simultaneous examination of cluster and individual-level influences on outcomes Adjustment of the result for between-cluster variation will thus be achieved The effects of the intervention on maternal and neonatal outcomes and changes in physical activity and diet will be analysed by using generalized linear latent and mixed models and multilevel mixed-effects linear regression by fitting random effects models All analysis will be performed in Stata SE version 17
Quality assurance strategy
From research team PI Co-PI and other investigators and local GOB health managers will work together for effective implementation monitoring and evaluation of interventions They will jointly monitor the progress and oversee any deviation from the protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None