Home » Trials » SLCTR/2023/023
Effectiveness of a behavior change intervention package on health literacy of behavioural risk factors of non-communicable diseases among health care assistants of government hospitals in Colombo district: Cluster randomized controlled trial
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SLCTR Registration Number
SLCTR/2023/023
Date of Registration
The date of last modification
Jan 31, 2024
Scientific Title of Trial
Effectiveness of a behavior change intervention package on health literacy of behavioural risk factors of non-communicable diseases among health care assistants of government hospitals in Colombo district: Cluster randomized controlled trial
Public Title of Trial
Effectiveness of a behavior change intervention package on health literacy of behavioural risk factors of non-communicable diseases among health care assistants of government hospitals in Colombo district: Cluster randomized controlled trial.
Disease or Health Condition(s) Studied
Health Literacy
Scientific Acronym
None
Public Acronym
None
Brief title
Effectiveness of a behavior change intervention package in improving health literacy on behavioural risk factors of non-communicable diseases among health care assistants of government hospitals in Colombo district
Universal Trial Number
U1111-1299-4066
Any other number(s) assigned to the trial and issuing authority
ERC: EC/23/061 Ethics Review Committee Faculty of Medicine University of Colombo
What is the research question being addressed?
Can a Behavior Change Intervention Package (BCIP), improve, health literacy based on Calgary charter, among Health Care Assistant (HCAs) of government hospitals in Colombo district
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Data analysts, Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
a) Study design: Cluster randomized controlled trial
b) Study setting: This study will be conducted in hospitals in Colombo district (Hospitals in Colombo district attached as annexure III)
c) Study population: Health care assistants working in government hospitals in Colombo district
d). Randomization: - Ten units per arm (Intervention and control arm) - Generating a random allocation sequence using a random number table - Allocation concealment: Twenty Hospitals will be selected using stratified cluster sampling method based on type of hospitals in Colombo district. Each hospital will be taken as cluster and there will be twenty clusters (hospitals).
Hospitals will be allocated to the intervention and the control groups by an independent person (Consultant Community Physician attached to MoH), who will not be involved in selection of participants, or any other activity related to this study (Concealment of allocation).
Required number of HCAs will be selected randomly from the pay roll of all HCAs attached to the hospital. It will be selected in three steps within the hospital. Step I: All HCAs will be listed out based on pay roll. Step II: Eligible HCAs will be selected based on inclusion and exclusion criteria. Step III: Required number of HCAs will be selected using simple random sampling (random table).
Intervention: Behaviour change Intervention Package (BCIP) will be delivered to the participants of the intervention arm. This package includes multiple interventions such as lectures, role playing sessions, brainstorming sessions, and small group discussions. This package will be delivered as two sessions per week for 8 weeks, total of sixteen sessions. Further it consists of Curriculum, Facilitator guide, Participants’ handbook, and Power point presentation for sixteen sessions in three mediums. (Curriculum is attached – Annex IV)
Control: Control group will only have the exposure to routine health system inputs and no intervention will be given. (Flow chart is attached – Annex V)
Healthcare providers and Data analysts will be blinded
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
HL.NCD: Health Literacy tool to assess NCD behavioral risk factors. It was developed and validated in the first component of this research. |
[ 12 weeks from initial assessment ] |
Secondary outcome(s)
|
1.
Secondary outcomes are behaviour change of pattern/frequency of Diet, frequency of physical activity, status/frequency of tobacco use and status/frequency of alcohol intake. It will be measured using STEP-wise-approach-toSurveillance (STEPS) of NCD risk factor questionnaire. |
[ 12 weeks from initial assessment ] |
Target number/sample size
240 - 120 in each arm
Countries of recruitment
Sri Lanka
Anticipated start date
2023-12-15
Anticipated end date
2024-07-31
Date of first enrollment
2023-12-15
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2023-09-21
Approval number
EC-23-061
Details of Ethics Review Committee
| Name: | Ethics Review Committee Faculty of Medicine University of Colombo |
| Institutional Address: | P O Box 271, Kynsey Road, Colombo 8, Sri Lanka |
| Telephone: | Telephone: +94-11-2695300 ext 240 Fax: +94-11-2691581 |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr M.M.M. Irshad
Registrar in Community Medicine
Directorate of NCD,
Ministry of Health
0773566565
0712747300
irshadim21@gmail.com
Contact Person for Public Queries
Dr. Dulani Samaranayake
Senior Lecturer
Department of Community Medicine,
Faculty of Medicine, University of Colombo,
Sri Lanka
+94- 071-6613296
dulani_samaranayake@yahoo.com
Primary study sponsor/organization
Directorate of Non Communicable diseases, Ministry of Health Sri Lanka.
385 Ven. Baddegama Wimalawansa Thero Mawatha, Maradana, Colombo
(94) 112 694033
info(at)health.gov.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Individual participant data that underlie the results being reported, after deidentification (text, tables, figures, and appendices) Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available at the University data warehouse but without investigator support other than deposited meta-data. Information regarding submitting proposals and accessing data may be found at irshadim21@gmail.com.
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
