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Randomized Controlled Trial
. 2025 Sep 30;25(1):3214.
doi: 10.1186/s12889-025-23969-6.

Effectiveness of pictorial educational intervention on foot care among individuals having type 2 diabetes at slums of Karachi, Pakistan: asingle blinded randomized control trial

Hina Sharif  1   2 , Masood Kadir  3 , Muzna Hashmi  3 , Sabahat Naz  3 , Iqbal Azam  3 , Asif Imam  4 , Muhammad Qamar Masood  5
Affiliations
Randomized Controlled Trial

Effectiveness of pictorial educational intervention on foot care among individuals having type 2 diabetes at slums of Karachi, Pakistan: asingle blinded randomized control trial

Hina Sharif et al. BMC Public Health. .

Abstract

Background: Diabetes elevates the chance of severe health complications, such as Diabetic Foot (DF), which detrimentally affects quality of life. A significant proportion of diabetes mellitus patients, particularly in the slums of Karachi, lack awareness of foot care, hence increasing their risk of foot ulcers and amputations. This exacerbates the healthcare cost owing to avoidable complications of diabetes.

Aim: The primary objective of this study was to evaluate the effectiveness of a pictorial infographic-based foot care education intervention among patients with diabetes in the slums of Karachi, Pakistan. By assessing the impact of this intervention, we aimed to provide valuable insights into the design of future diabetes care and education programs.

Methodology: A single-blinded randomized control trial was conducted at one clinic of the primary healthcare organization SINA, providing primary healthcare services in slums. Using repeated measures of ANOVA to evaluate the effect of group (intervention vs. control), time (pre-and post), and their interaction on scores and pair t-test to check the mean difference of scores in intervention and control group at baseline and after 3 months. The data were cleaned and analyzed in STATA 17.

Results: Of 180 individuals, 90 were in each arm-intervention and control. In the intervention arm, 83 completed follow-up and 77 in the control. In the control and interventional groups, 77.9% and 80.7% of 160 participants were female. Participants' mean age, BMI, and diagnosis years were 54.92 ± 10.41 years, 28.99 ± 6.22, and 7.99 ± 6, respectively. The repeated measures ANOVA showed significant main effects for both groups (F (1, 158) = 45.65, p < 0.0001) and time (F(1, 158) = 172.30, p < 0.0001), showing significant changes in scores. A substantial interaction effect between group and time indicates that ratings changed differently over time for the two groups. The intervention affected the groups differently, with considerable variations over time. Additionally, after education intervention, the intervention arm showed a significant improvement in mean difference (mean difference: 3.53, 95% CI 3.11-3.96, p < 0.001) compared to the control group (mean difference: 0.87, 95% CI 0.34-1.40, p < 0.001) from baseline.

Conclusion: Education had a crucial role in positively impacting patient behavior. Therefore, patients must be actively involved in their healthcare education awareness, focusing more on modifying their behavior.

Trial registration: ClinicalTrials.gov NCT06358846.

Keywords: Educational intervention; Foot-care; Pictorial infograph; Randomized control trial; Self-care; Slums; Type 2 diabetes.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study was conducted in accordance with the ethical principles of the Declaration of Helsinki. Prior to conducting the study, This research was registered in clinictrials.gov with registration number was NCT06358846,with formal authorization from the Departmental Research Committee (DRC) of community health sciences and the Ethical Review committee (ERC) of Aga Khan University Hospital with approval # 2024-9859-28867. Before the commencement of study, Patients were then requested to provide informed verbal and written permission, ensuring that they are fully aware of the nature and aim of the study. Additionally, patients were guaranteed that any information received would be treated with utmost secrecy and only used for research purposes. Consent for publication: All authors read and agreed to publish this material. Patient and public involvement: Patients and public were not involved in the design of the study. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Consort diagram of the study
Fig. 2
Fig. 2
Interaction plot of scores changes of educational intervention over time between Group 1 (Intervention arm) and Group 2 (control arm)
Fig. 3
Fig. 3
Box Plot for comparison across pre, post intervention and control arms scores
See this image and copyright information in PMC

References

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