Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202310841894237 Date of Approval: 05/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of an environmental educational program on the knowledge and practices of diabetic patients regarding sharps waste disposal
Official scientific title The effect of an environmental educational program on the knowledge and practices of diabetic patients regarding sharps waste disposal at home, Alexandria, Egypt
Brief summary describing the background and objectives of the trial Objective: The current study aimed to assess the effect of a unique environmental educational program on the knowledge and practices of diabetic patients regarding sharps waste disposal. Background: The disposal of generated sharps from diabetic patients has been cited as a public health, environmental health, and financial concern. While there is a wealth of literature on sharp disposal practices in healthcare settings, sharp disposal practices have been poorly reported for diabetic patients living at home. Worldwide studies have shown that people with diabetes dispose of medical waste improperly. Scavenging at waste disposal sites, as well as the processing and manual sorting of hazardous medical waste generated either from health care facilities or home care, pose additional risks. These practices are widespread throughout the world, particularly in low- and middle-income countries. Waste handlers are immediately exposed to needle-stick injuries and poisonous or infectious materials.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diabetes
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/11/2022
Actual trial start date 15/11/2022
Anticipated date of last follow up 18/04/2023
Actual Last follow-up date 27/04/2023
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group An environmental educational program The program was conducted within 5 weeks in three educational sessions for each group. Each session lasted for 30-45 minutes. The intervention group members (50 patients) were divided into 5 groups of 10 patients each. Thus, 15 sessions were conducted. 5 weeks We conducted the study in three phases as follows: Phase I: A preintervention phase: A predesigned interview questionnaire: An Arabic questionnaire about the disposal of sharps related to insulin therapy was developed by a previous study The first part of the questionnaire was concerned with socio-demographic data, the second part covered the medical characteristics of diabetic patients such as medical history, duration of diabetes, type of insulin injection, and duration of insulin use, the third part of the questionnaire assessed knowledge through ten items. A correct answer received a '1' score and an incorrect answer received a '0' score. The fourth part assessed the practice through three subdivisions. Phase II: Intervention phase The intervention group received the environmental educational program. The program consisted of 2 main components educational part, and the sharps disposal and syringe exchange procedure, at the end of the third educational session, the patients were provided with new plastic puncture-resistant containers (sharp pins). The new syringes, needles, and sharps disposal containers were distributed to participants instead of used ones in the first and second post-intervention visits whereas, the nonintervention group did not receive any intervention. Phase III: Postintervention phase The effect of the program was evaluated by comparing pre-and-post assessments by the questionnaire and observation by the researcher between intervention and nonintervention groups and within groups at baseline, and two-, and four-month intervals. Returned sharps containers with used syringes, needles, and lancets were collected and calculated to measure the percentage of returned tools hence, the effect of the educational program could be assessed. 50
Control Group Assessment of knowledge and attitude of health care workers at baseline 2 months and 4 months interv Non 4 months the control group did not receive the program 50 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants were eligible for this study if they were adult diabetic patients receiving regular insulin injections for more than one month, whether type 1 or type 2, and attended El-Horraya Polyclinic, Alexandria, Egypt. The study did not include pregnant women who had gestational diabetes. Adult: 19 Year-44 Year 30 Year(s) 67 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/12/2022 The Institutional Ethics Committee at the High Institute of Public Health Alexandria University Egypt
Ethics Committee Address
Street address City Postal code Country
165 Elhorraya Street Alibrahimia Alexandria 5422031 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The first post-intervention visit results show that the participants of the intervention group had a higher median knowledge percentage score of 80 (80-90) which indicated a good knowledge level in both analyses, as compared to the nonintervention group with percentage scores of 70 (60-90) and 75 (60-90) according to intent to treat analysis and per protocol analyses respectively and the difference reached statistical significance (p<0.001). Afterward, at the second postintervention visit, we identified a higher median knowledge score of 80 (80-90) in the intervention group than in the nonintervention group at 70 (60-90) according to both analyses (p<0.001) and the difference was statistically significant. Regarding the practice, at the end of the program, there was a statistically remarkable difference between groups in the median of the participants' overall practice scores, with the intervention group significantly outperforming the nonintervention group and registering a score of 14 which matched the good practice level, while the nonintervention group stopped unchanged at 4.4, which corresponds to a poor practice level. Baseline, 2 months, and 4 months intervals
Secondary Outcome At the first postintervention visit, it was found that the proportion of participants with a good knowledge level in the intervention group improved to 98% and 100% from 40% and 41% at baseline according to intent to treat and per protocol analyses and was higher than that of the nonintervention group which recorded 62% and 65% (p <0.001) according to the same analyses. Moreover, the proportion of study subjects with a good level of knowledge in the intervention group at the second post-intervention visit was 96% and 98% according to the intent to treat and per protocol analyses in contrast to 64% and 67% in the nonintervention group (p <0.001). At the first postintervention visit, it was found that the proportion of participants with good practice level in the intervention group increased significantly from 0% at baseline to 68% and 69% according to intent to treat and per protocol analyses respectively whereas in the nonintervention group, it remained unchanged at 4% in both analyses (p <0.001). Moreover, the proportion of respondents with a good practice level in the intervention group at the second post-intervention visit was 84% and 86% according to intent to treat and per protocol analyses respectively, in contrast to 4% (both analyses) in the nonintervention group which remained unchanged from the previous visit (p <0.001). At baseline, 2 months, and 4 months intervals
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Elhorraya Dibetic Center 11 El-Horraya Street - El Attarin Alexandria 21131 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded 246 Namallah Street Elmandara Elbaharia Alexandria 21923 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hossam Mohamed Hasaan Soliman 246 Street Elmandara Elbaharia Alexandria 21923 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hossam Mohamed Hassan Soliman hiph.hossamsoliman@alexu.edu.eg +201009835966 246 Street Elmandara Elbaharia
City Postal code Country Position/Affiliation
Alexandria 21923 Egypt Clinical Research Department Director at Health Insurance Organization Alexandria Egypt
Role Name Email Phone Street address
Public Enquiries Ebtisam Mohamed Fetohy ebtisamfetohy@yahoo.com +201014108182 165 Elhorraya Street Alibrahimia
City Postal code Country Position/Affiliation
Alexandria 5422031 Egypt Professor of Health Education and Behavioural Sciences High Institute of Public Health Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Fakhry Hussein hiph-mohamedfakhry@alexu.edu.eg +201271266332 165 Elhorraya Street Alibarahimia
City Postal code Country Position/Affiliation
Alexandria 5422031 Egypt Lecturer of Environmental Health Department of Occupational Health and Industrial Medicine High Institute of Public Health Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data (IPD) Sharing is available. The raw data such as the master table sheet, questionnaire, Arabic consent form, and statistical analysis are available upon reasonable request through PI E-MAIL: hiph.hossamsoliman@alexu.edu.eg Informed Consent Form,Statistical Analysis Plan,Study Protocol 3 years The data access is open. The results, statistical analysis, questionnaire, Arabic informed consent, and protocol are available on request through PI e-mail: hosamhsn1972#gmail.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 23/09/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 23/09/2023 Result - 23/09/2023 Result - 23/09/2023 Result - 23/09/2023 Result - 23/09/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://drive.google.com/file/d/1-MtBnX9yPA2Z1KF6U2SZgMR0qsgw1Alm/view?usp=drivesdk
Changes to trial information