Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001261707
Ethics application status
Approved
Date submitted
11/11/2013
Date registered
18/11/2013
Date last updated
18/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
NIGRAAN: Strengthening Supervisory System of Pakistan’s Lady Health Workers Programme
Scientific title
Enhancing Lady Health Workers' (LHWs) skills through structured supportive supervision by Lady Health Supervisors (LHSs) in selected rural communities and its impact on childhood pneumonia and diarrhea.
Secondary ID [1] 283561 0
Nil
Universal Trial Number (UTN)
U1111-1149-6604
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia and Diarrhoea

Supervisory skills of lady health supervisors (LHS)
 290467 0
Condition category
Condition code
Public Health 290859 290859 0 0
Health promotion/education
Public Health 290860 290860 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Project NIGRAAN is a two year long community based intervention trial aiming to explore whether structured supportive supervision by LHS of LHWs results in improved health of children under five.

The intervention consists of:

a. Training
i. Develop knowledge and skills of LHSs for Community Case Management (CCM) of pneumonia and diarrhoea in children under five
ii. Develop clinical mentoring skills of LHSs
iii. Strengthen supportive feedback skills of LHSs

b. Supervisory tools

i. Modified Supervisory Checklist:
ii. The Supervisor’s Tally Sheet for Compilation of Quality of Case Management
iii. LHS Feedback Card for Individual LHWs.


LHSs would be provided training in a 4 day workshop during which a ‘Training Consultant’—taken on board for this particular task—would facilitate them in terms of improving their theoretical understanding of the approaches for community case management of Diarrhoea and Pneumonia, clinical mentoring skills (LHSs skills in assisting LHWs improve their case management skills) and supervisory skills (LHSs skills in providing verbal and written feedback to improve LHW performance and case management practices). The face to face learning would be complemented by hands on training and practical exercises in a simulated environment as well as in the real life settings. The curriculum and relevant content for the training package (which actually is the intervention—The NIGRAAN Training Package—to be finalized after completion of the qualitative/formative phase of the study. The findings from this phase would identify the gaps in the current level of understanding of LHWs and LHSs in regard to community case management of diarrhoea and pneumonia as well as clinical mentoring and supervisory skills of LHSs. The instructional methodologies used during the training would be interactive lectures complemented with audio-visual aids/videos (to be sourced through WHO), role plays, problem based learning in the form of practical exercises and group work. All these approaches coupled with the relevant content will help LHSs refine their understanding of community case management of diarrhoea and pneumonia as well as clinical mentoring and supervisory skills.

The 4 day 'NIGRAAN' training package to be offered at the beginning of 7-8 month of the study. These would be full working day workshops conducted in two to three separate sessions as per the design of the training. The refresher training to last for 2 days at the beginning of 13-14 month of the study.

The training would be provided by an 'Expert Training Consultant' hired by the project in this regard. The person specifications would include a qualified paediatrician with public health exposure and familiarity with training community based peripheral health workers.

The modified supervisory checklist has been adapted from the existing tools available to the LHSs through Pakistan's Lady Health Worker Programme but they are not widely used in practice. It adds certain components (Strengthening Monitoring by LHS of community Case Management Skills of LHW and Direct Observation) and has been organized for the better comprehension. The tally sheet is the consolidated version of the modified supervisory checklist providing at a glance view of the progress and quality of case management as well as picks up the gaps in case management practices of LHWs working under a given LHS. LHSs feedback card is study specific innovation to introduce the practice of written feedback to be provided to LHWs through LHSs.
Intervention code [1] 288257 0
Treatment: Other
Intervention code [2] 288258 0
Behaviour
Comparator / control treatment
Standard Routine Training as per National Programme for Family Planning and Primary Healthcare (The Lady Health Workers Programme)

The routine training differs in terms of the training provider (usual Department of Health Staff, a clinician or a lady health visitor compared to qualified Paediatrician in NIGRAAN); the content and curriculum (routine training lacks emphasis on clinical mentoring, supervisory and feedback skills whereas NIGRAAN aims to strengthen these components) and teaching/instructional pedagogies.
Control group
Active

Outcomes
Primary outcome [1] 290857 0
Reduction in under five morbidity attributable to pneumonia and diarrhea in children under five as assessed by household survey and the on-going Management Information System (MIS).
Timepoint [1] 290857 0
Baseline Household Survey at 3-5 months of the study lifecycle, pre-intervention; End-line Household Survey after 18th month, post-intervention.
Secondary outcome [1] 305468 0
Improved perceptions, knowledge and skills and among LHSs for CCM of pneumonia and diarrhoea in children under five as gauged through:

a) Qualitative Tools: Focus Group Discussions (FGDs) and Key Informant Interviews

b) Quantitative Assessments: Knowledge Assessment Questionnaire and Skills Assessment Scorecards
Timepoint [1] 305468 0
Qualitative inquiry at the baseline (at 1-3 months of the study lifecycle); during intervention phase (month 10 and 16) and one year after roll-out of the intervention (19-21 months of the study lifecycle)

Knowledge assessment at the time of roll-out of intervention (NIGRAAN Training) at the beginning of month 7 of the study lifecycle and thereafter at the intervals of 3 months till the conclusion of intervention phase at the end of month 18

Clinical Skills assessment at the time of roll-out of intervention (NIGRAAN Training) at the beginning of month 7 of the study lifecycle and thereafter at the intervals of 3 months till the conclusion of intervention phase at the end of month 18

Supervisory skills and clinical mentoring skills of LHS to be assessed at the time of roll-out of intervention (NIGRAAN Training) at the beginning of month 7 of the study lifecycle and thereafter at the intervals of 3 months till the conclusion of intervention phase at the end of month 18
Secondary outcome [2] 305469 0
Improvement in LHW perceptions, knowledge, skills and performance as a result of structured supportive supervision by LHSs as gauged through:

a) Qualitative Tools: Focus Group Discussions (FGDs) and Key Informant Interviews

b) Quantitative Assessments: Knowledge Assessment Questionnaire and Skills Assessment Scorecards
Timepoint [2] 305469 0
Qualitative inquiry at the baseline (at 1-3 months of the study lifecycle); during intervention phase (month 10 and 16) and one year after roll-out of the intervention (19-21 months of the study lifecycle)

Knowledge assessment at the time of roll-out of intervention (NIGRAAN Training) at the beginning of month 7 of the study lifecycle and thereafter at the intervals of 3 months till the conclusion of intervention phase at the end of month 18

Clinical Skills assessment at the time of roll-out of intervention (NIGRAAN Training) at the beginning of month 7 of the study lifecycle and thereafter at the intervals of 3 months till the conclusion of intervention phase at the end of month 18
Secondary outcome [3] 305470 0
Increased knowledge of community caregivers for CCM of pneumonia and diarrhoea in children under five assessed through Household Survey Questionnaire
Timepoint [3] 305470 0
Baseline Household Survey at 3-5 months of the study lifecycle, pre-intervention; End-line Household Survey after 18th month, post-intervention

Eligibility
Key inclusion criteria
Lady Health Supervisor (LHS):
1. LHS who is performing duties as part of National
Program of Family Planning and Primary Health
care within geographical boundaries of District
Badin
2. LHS whose employments terms are permanent
3. LHS who conduct ‘field monitoring visits’ and
report them to the district level authorities.
4. LHS supervising the LHWs whose catchment area
is accessible for the purpose of ‘field monitoring
visits’.

Lady Health Worker(LHW):
1. LHW who is performing duties as part of National
Programme of Family Planning and Primary Health
care within geographical boundaries of District
Badin
2. LHW who provides services to the households
per LHW programme objectives, collect, collate
and report the relevant data to the respective
supervisor/LHS.
3. LHW whose catchment area is accessible by her
LHS for the purpose of ‘Filed Monitoring Visits’.

At Community Level:
1. Community caregiver/parent/guardian
permanently residing in the household falling
under the geographical scope/coverage area of
the LHW enrolled into the study
2. Community caregiver residing in a household that
has at least one child less than five years of age
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Lady Health Supervisor (LHS):
1. LHS who is employed on ‘ad hoc’ or ‘temporary’
basis
2. LHS who assumes the additional responsibilities
of higher management level for e.g., Additional
District Controller
3. LHS not conducting ‘field monitoring visits’ on a
regular basis and also not reporting the progress
of the LHWs working under her supervision to the
next level of LHW programme authority


Lady Health Worker (LHW):
1. LHW not providing services; collecting, collating
and reporting the data relevant to the
households under her coverage area per LHW
programme objectives
2. LHW whose catchment area is not accessible by
her LHS

At Community Level:
1. Community caregiver who is not the permanent
resident of District Badin
2. Community caregiver having a household with no
child less than five years of age

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each Lady Health Supervisor (LHS) working in Badin, Sindh is labeled as a cluster. The enrolment of LHS into the trial is according to the criteria mentioned below:

1. Proximity of LHS’s assigned workers to the health facility
2. Regular visits of the LHS to the areas covered by her workers
3. Collection of relevant data from the field-site by her workers
4. Compiling of relevant data for reporting
5. Should have at least 5 lady health workers whose catchments areas are accessible for ‘field monitoring visits’

The allocation to intervention was blinded and was carried out by a neutral person through computer generated randomized tables.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The LHS has been randomized to intervention and control arms via simple randomization using a randomization table generated by computer software MS Excel.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The assumptions that were used to calculate the sample size are explained below:


1. Average risk in communities without the intervention:

In this study, average risk in communities without the intervention refers to an estimation of those children who receive antibiotic for pneumonia. Proportion of children under 5 years of age who are given antibiotic for ARI in Sindh is 41 percent.


2. Range of risks across communities without intervention:

The assumption for lowest and highest proportion of children receiving antibiotics from LHWs is 31 and 51 percent (+/-10% from the average risk) respectively.

3. Average risk in communities with intervention:

We expect a 15 percent increase in the proportion of children with respiratory infection who will receive antibiotics from the baseline in the intervention arm as compared to the control arm.


4. Average number of individuals per community/cluster:

This is estimated based on the expected number of children under five, who experience an episode of pneumonia per year. The estimated incidence of pneumonia among children under five in Pakistan is 0.41 episodes per child-year (e/cy).


Plan of Statistical Analysis:
Data would be analysed in SPSS version 21/22 or Stata 12; following steps to be undertaken as part of analytic plan:

1.Effect measures and statistical models to address
primary and secondary objectives to be conceptualized, for e.g:


Primary outcome:
Effect measures (reduction in number of cases of diarrhea and pneumonia over the study lifecycle, mean duration of illness) to be compared between the intervention and control arms. Similarly comparison of baseline and end- line statistics regarding the odds of occurrence of diarrhea and pneumonia between the intervention and control arms.


Secondary outcome 1 and 2:

Effect measures (mean scores on knowledge and skills assessment at different timepoints) would be compared between the two arms, for both for LHS (Secondary Outcome 1) and LHWs (Secondary Outcome 2)


Secondary Outcome 3:
Knowledge of community caregivers regarding CCM of Diarrhoea and Pneumonia to be compared between the two arms, both at the baseline as well as end-line.


2. Confounders (socioeconomic profile, education, health seeking behaviour, presence in the community of other health awareness programmes and campaigns organized by NGOs and/or government agencies, health and hygiene information disseminated through different media like TV channels and newspapers) will be identified during analysis of the data and would be controlled for using appropriate statistical methods (e.g, regression analysis).


Qualitative Data Analysis:

Qualitative data analysis would be done in NVivo. The audio recordings of the Focus Group Discussions and Key Informant Interviews would be transcribed verbatim and would then be translated in ‘English’.
The data would then be imported into NVivo; ideas, themes and theoretical constructs would then be coded generating the coding template or scheme. Thematic analysis would be performed using ‘framework analysis’ approach or other appropriate analytical approaches.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/11/2013
Actual
Date of last participant enrolment
Anticipated
15/06/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment outside Australia
Country [1] 5578 0
Pakistan
State/province [1] 5578 0
Sindh

Funding & Sponsors
Funding source category [1] 288244 0
Other
Name [1] 288244 0
Department of Maternal, Newborn, Child and Adolescent Health,
World Health Organization
Country [1] 288244 0
Switzerland
Primary sponsor type
University
Name
The Aga Khan University, Karachi
Address
Stadium Road, P. O. Box. 3500, Karachi 74800, Pakistan
Country
Pakistan
Secondary sponsor category [1] 286964 0
None
Name [1] 286964 0
Address [1] 286964 0
Country [1] 286964 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290150 0
Ethical Review Committee (ERC), The Aga Khan University, Karachi.
Ethics committee address [1] 290150 0
Ethics committee country [1] 290150 0
Pakistan
Date submitted for ethics approval [1] 290150 0
Approval date [1] 290150 0
22/08/2013
Ethics approval number [1] 290150 0
(Human Research Ethics Committee Identification Number). 2650-CHS-ERC-13
Ethics committee name [2] 290151 0
WHO-ERC (Ethics Review Committee)
Ethics committee address [2] 290151 0
Ethics committee country [2] 290151 0
Switzerland
Date submitted for ethics approval [2] 290151 0
Approval date [2] 290151 0
07/08/2013
Ethics approval number [2] 290151 0
WHO-ERC reference number MCA00113.

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44194 0
Prof Fauziah Rabbani
Address 44194 0
Department of Community Health Sciences,
The Aga Khan University,
Stadium Road, PO Box 3500,
Karachi 74800, Pakistan
Country 44194 0
Pakistan
Phone 44194 0
+92 21 3486 4800, +92 21 3486 4801
Fax 44194 0
+92 21 3493 4294, +92 21 3493 2095
Email 44194 0
[email protected]
Contact person for public queries
Name 44195 0
Selwyn Oswald Victor
Address 44195 0
Department of Community Health Sciences,
The Aga Khan University,
Stadium Road, PO Box 3500,
Karachi 74800,
Pakistan
Country 44195 0
Pakistan
Phone 44195 0
+92 21 3486 4845
Fax 44195 0
+92 21 3493 4294, +92 21 3493 2095
Email 44195 0
[email protected]
Contact person for scientific queries
Name 44196 0
Fauziah Rabbani
Address 44196 0
Department of Community Health Sciences,
The Aga Khan University,
Stadium Road, PO Box 3500,
Karachi 74800,
Pakistan
Country 44196 0
Pakistan
Phone 44196 0
+92 21 3486 4800, +92 21 3486 4801
Fax 44196 0
+92 21 3493 4294, +92 21 3493 2095
Email 44196 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Research Objective: To assess the effect of enhan... [More Details]
Other filesNo
Study results articleYes Rabbani, F., Gul, A., & Perveen, S., (2012). Overc... [More Details]
Study results articleYes Rabbani, F., Mukhi, A. A. A., Perveen, S., Gul, X.... [More Details] 365284-(Uploaded-26-07-2019-21-21-26)-Journal results publication.PDF
Study results articleYes Rabbani, F., Zahidie, A., & Sangrasi, K. (2015). C... [More Details] 365284-(Uploaded-29-07-2019-19-34-03)-Journal results publication.pdf
Study results articleYes Zahidie, A., Sangrasi, K., Iqbal, S., Perveen, S.,... [More Details] 365284-(Uploaded-29-07-2019-19-35-48)-Journal results publication.pdf
Study results articleYes Rabbani, F., Naeem, I., Leah, S., Beenish, M., Ays... [More Details] 365284-(Uploaded-29-07-2019-19-53-14)-Journal results publication.pdf
Study results articleYes Rabbani, F., Perveen, S., Aftab, W., Zahidie, A., ... [More Details] 365284-(Uploaded-29-07-2019-19-56-07)-Journal results publication.pdf
Study results articleYes Rabbani, F., Shipton, L., Aftab, W., Sangrasi, K.,... [More Details] 365284-(Uploaded-29-07-2019-19-57-17)-Journal results publication.pdf
Study results articleYes angrasi, K., Rabbani, F., Aftab, W., Zahidie, A., ... [More Details] 365284-(Uploaded-29-07-2019-19-59-20)-Journal results publication.pdf
Study results articleYes Rabbani, F., Zahidie, A. (2016). Recent strategies... [More Details] 365284-(Uploaded-29-07-2019-20-03-55)-Journal results publication.pdf
Study results articleYes Aftab, W., Shipton, L., Rabbani, F., Sangrasi, K.,... [More Details] 365284-(Uploaded-29-07-2019-20-13-11)-Journal results publication.pdf
Study results articleYes Aftab, W., Rabbani, F., Sangrasi, K., Perveen, S.,... [More Details] 365284-(Uploaded-29-07-2019-20-17-00)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImproving community case management of diarrhoea and pneumonia in district Badin, Pakistan through a cluster randomised study--the NIGRAAN trial protocol.2014https://dx.doi.org/10.1186/s13012-014-0186-9
Dimensions AIImproving community health worker performance through supportive supervision: a randomised controlled implementation trial in Pakistan2018https://doi.org/10.1111/apa.14282
N.B. These documents automatically identified may not have been verified by the study sponsor.