Skip to content
2000
image of Development and Impact of a Patient Information Leaflet on the Knowledge of Patients with Diabetes: A Validation Study

Abstract

Background

Diabetes management is critical for patient health, yet many individuals lack essential knowledge about their condition.

Aim

This study aimed to develop and validate a patient information leaflet (PIL) focused on diabetes, assessing its effectiveness in enhancing patient knowledge among individuals with diabetes.

Objective

The primary objective was to prepare and validate a patient information leaflet (PIL) on diabetes and evaluate its impact on patient knowledge among diabetic individuals. The secondary objective was to analyze demographic factors, education, family history, and comorbidities influencing baseline knowledge and post-intervention knowledge improvement.

Methods

Quasi-experimental pre and post-test design was carried out enrolling 78 inpatients and outpatients diagnosed with T1DM or T2DM. The PIL was developed using evidence-based resources and validated through expert panel reviews. Its readability was evaluated using Flesch Reading Ease (FRE) and Flesch-Kincaid Grade Level (FK-GL) scales, with additional validation through user testing. The leaflet’s design adhered to Baker-Able Leaflet Design (BALD) principles. Pre- and post-intervention knowledge was measured through a structured questionnaire, and participant feedback on the leaflet's content and layout was collected.

Results

The FRE and FK-GL scores for the PIL were 60.3 and 8, respectively. The BALD scores for the English and Kannada versions were 25 and 24, respectively. User testing revealed significant improvements in knowledge, with mean scores increasing from 33.85 ± 23.43 to 93.23 ± 8.58 for the Kannada PIL and from 59.23 ± 24.31 to 93.08 ± 9.47 for the English PIL. A total of 85.9% of participants rated the leaflet as effective in improving their understanding of diabetes management.

Conclusion

The validated PIL significantly enhanced patient knowledge of diabetes. These findings suggest that such educational tools can effectively support patient education in both T1DM and T2DM populations.

© 2025 Bentham Science Publishers
Loading

Article metrics loading...

/content/journals/cdth/10.2174/0115748855368265250312032743
2025-06-23
2025-09-11

  • From This Site

    /content/journals/cdth/10.2174/0115748855368265250312032743
    dcterms_title,dcterms_subject,pub_keyword
    -contentType:Contributor -contentType:Concept -contentType:Institution
    10
    5
Loading full text...

Full text loading...

References

  1. Dipiro J.T. Talbert R.L. Yee G.C. Wells B.G. Posey L.M. Pharmacotherapy A Pathophysiologic Approach. 6th ed New York McGraw Hills Education 2005 1333
    [Google Scholar]
  2. Kodakimble M.A. Young L.Y. Alldredge B.K. Applied Therapeutics-The Clinical use of Drugs. 9th ed USA Lippincott Williams and Wilkin 2008 1226 1237
    [Google Scholar]
  3. Walker R. Whittlesea C. Clinical Pharmacy and Therapeutics. 5th ed Elsevier Health Sciences 2011 685 710
    [Google Scholar]
  4. Diabetes Latest. 2022 Available from: www.cdc.gov/features/diabetesfactsheet
  5. Diabetes. 2023 Available from: https://www.who.int/health-topics/diabetes#tab=tab_1
  6. Gonimathad K.M.V. A Textbook of community Pharmacy Practice Chittara Publications Davangere 2010
    [Google Scholar]
  7. Adepu R. Community Pharmacy Practice. 1st ed BSP Books 2015 43 50
    [Google Scholar]
  8. Nagavi B.G. Adepu R. Rasheed A. Effect of patient counseling on quality of life in type-2 diabetes mellitus patients in two selected South Indian community pharmacies: A study. Indian J. Pharm. Sci. 2007 69 4 519 524 10.4103/0250‑474X.36937
    [Google Scholar]
  9. Vooradi S. D Acharya L. Seshadri S. Thunga G. Vijayanarayana K. Preparation, validation and user-testing of patient information leaflets on diabetes and hypertension. Indian J. Pharm. Sci. 2018 80 1 118 125 10.4172/pharmaceutical‑sciences.1000336
    [Google Scholar]
  10. Caetano I.R.C.E.S. Santiago L.M. Marques M. Impact of written information on control and adherence in type 2 diabetes. Rev Assoc Med Bras 2018
    [Google Scholar]
  11. Munsour E.E. Awaisu A. Ahmad Hassali M.A. Dabbous Z. Zahran N. Abdoun E. Impact of customized-consumer medication information on health-related quality of life among patients with type 2 diabetes mellitus. Res. Social Adm. Pharm. 2020 16 6 793 799 10.1016/j.sapharm.2019.08.038 31542446
    [Google Scholar]
  12. Munsour E.E. Awaisu A. Hassali M.A.A. Abdoun E. Dabbous Z. Zahran N. Ali H. The effect of tailored consumer medicine information on patients with type 2 diabetes mellitus: A randomised controlled interventional study. Int. J. Clin. Pract. 2020 74 8 e13527 10.1111/ijcp.13527 32386077
    [Google Scholar]
  13. Gangol R. Maharjan D. Information leaflet as an adjunct to verbal counseling in obtaining informed consent. JNMA J. Nepal Med. Assoc. 2010 49 178 117 120 10.31729/jnma.110 21485596
    [Google Scholar]
  14. Des Jarlais D.C. Lyles C. Crepaz N. TREND Group Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Am. J. Public Health 2004 94 3 361 366 10.2105/AJPH.94.3.361 14998794
    [Google Scholar]
  15. Vinay B.C. Shastry C.S. Kodangala S. Mateti U.V. Bhat K. Development and validation of patient information leaflet for coronary heart disease patients. Perspect. Clin. Res. 2021 12 2 83 86 10.4103/picr.PICR_58_19 34012904
    [Google Scholar]
  16. Parthasarathi G. Hansen K.N. Nahata M.C. A Textbook of Clinical Pharmacy Practice 2012
    [Google Scholar]
  17. Raman-Wilms L. The pharmacist as patient educator. Can. J. Hosp. Pharm. 2009 62 2 93 98 10.4212/cjhp.v62i2.436 22478873
    [Google Scholar]
  18. Shareef J. Fernandes J. Samaga L.N. Bhat M.L. Development, quality and readability assessment of patient information leaflet for diabetes mellitus. Diabetes Obes. Int. J. 2016 1 6 10.23880/DOIJ‑16000135
    [Google Scholar]
  19. Hill J. Bird H. The development and evaluation of a drug information leaflet for patients with rheumatoid arthritis. Br. J. Rheumatol. 2003 42 1 66 70 10.1093/rheumatology/keg032 12509615
    [Google Scholar]
  20. Moult B. Franck L.S. Brady H. Ensuring Quality Information for Patients: development and preliminary validation of a new instrument to improve the quality of written health care information. Health Expect. 2004 7 2 165 175 10.1111/j.1369‑7625.2004.00273.x 15117391
    [Google Scholar]
  21. Herber O.R. Gies V. Schwappach D. Thürmann P. Wilm S. Patient information leaflets: informing or frightening? A focus group study exploring patients’ emotional reactions and subsequent behavior towards package leaflets of commonly prescribed medications in family practices. BMC Fam. Pract. 2014 15 1 163 10.1186/1471‑2296‑15‑163 25277783
    [Google Scholar]
  22. Algabbani A.M. Alzahrani S.A. Almomen S.M. Hafiz R.A. Readability of information imprinted in patient information leaflets (PILs) in Saudi Arabia: The case of antihypertensive medications. Explor. Res. Clin. Soc. Pharm. 2022 8 100179 10.1016/j.rcsop.2022.100179 36177271
    [Google Scholar]
  23. Roy R. Sekhar M. Rodrigues G. Rajesh V. Preparation and readability assessment of patient information leaflets for diabetic foot ulcers. J Soc Health Diabetes. 2013 1 2 079 081 10.4103/2321‑0656.115304
    [Google Scholar]
  24. Sekhar M S. Mk U. Vyas N. Rodrigues G.S. Development and evaluation of patient information leaflet for diabetic foot ulcer patients. Int. J. Endocrinol. Metab. 2017 55 3 e55454 10.5812/ijem.55454 29201075
    [Google Scholar]
  25. Adepu R. Swamy M.K. Development and evaluation of patient information leaflets (PIL) usefulness. Indian J. Pharm. Sci. 2012 74 2 174 178 10.4103/0250‑474X.103857 23326002
    [Google Scholar]
  26. Arul K.K.S.G. Yohannan J.K. John J. Palanisamy S. Jacob S. Development and implementation of patient information leaflet on Hypertension and to assess its effectiveness. Int. J. Pharm. Tech. Res. 2009 1 3 712 719
    [Google Scholar]
  27. Sarfaraz M.D. George A. Nivya S. Gaffar P.A. Development and Evaluation of Patient Information Leaflet Usefulness in Patients with Hypertension in a Tertiary Care Teaching Hospital. Manipal J. Pharm. Sci. 2020 6 2 79 86
    [Google Scholar]
  28. Priya J.K. Balambigai M.S. Sariga N.P. Sathya M. Andhuvan G. Development and validation of patient information leaflet for heart attack patients. Int. J. Pharm. Pharm. Sci. 2016 8 381 383
    [Google Scholar]
  29. Mateti U.V. Nagappa A.N. Attur R.P. Bairy M. Nagaraju S.P. Mallayasamy S. Vilakkathala R. Guddattu V. Balkrishnan R. Preparation, validation and user-testing of pictogram-based patient information leaflets for hemodialysis patients. Saudi Pharm. J. 2015 23 6 621 625 10.1016/j.jsps.2015.01.022 26702256
    [Google Scholar]
  30. Nandakumar U.P. Joel J.J. Shetty J. Shastry C.S. Krishna Bhat C.H. Preparation, validation and user-testing of patient information leaflet on cancer. Pharm. Hosp. Clin. 2021 56 1 12 17 10.1016/j.phclin.2020.07.012
    [Google Scholar]
  31. Surulivelrajan M. Mathew Joy, Suhaj A, Rajesh V, Mohan KM. Study to Assess the Utility of Cloze Test in Readability Assessment of Patient Information Leaflets in English and Indian Languages. Asian J Pharm Health Sci 2013 3 4 824 829
    [Google Scholar]
  32. Shrestha A. Rajesh V. Dessai S.S. Stanly S.M. Mateti U.V. Preparation, validation and user-testing of pictogram-based patient information leaflets for tuberculosis. Pulm. Pharmacol. Ther. 2018 51 26 31 10.1016/j.pupt.2018.05.002 29807128
    [Google Scholar]
  33. Amin R. Kumar Dey B. Abdulsalim S. K Manu M. Preparation and Validation of User-based Patients Information Leaflets (PILs) for COPD Patients in Indian Regional Languages: A Prospective Observational Study. Int. J. Pharm. Investig. 2021 11 2 244 247 10.5530/ijpi.2021.2.43
    [Google Scholar]
  34. Williamson J.M.L. Martin A.G. Analysis of patient information leaflets provided by a district general hospital by the Flesch and Flesch-Kincaid method. Int. J. Clin. Pract. 2010 64 13 1824 1831 10.1111/j.1742‑1241.2010.02408.x 21070533
    [Google Scholar]
/content/journals/cdth/10.2174/0115748855368265250312032743
Loading
Development and Impact of a Patient Information Leaflet on the Knowledge of Patients with Diabetes: A Validation Study
Bentham Science Publishers ; https://doi.org/10.2174/0115748855368265250312032743
/content/journals/cdth/10.2174/0115748855368265250312032743
/content/journals/cdth/10.2174/0115748855368265250312032743
Loading

Data & Media loading...


  • Article Type:     Research Article
Keywords: patient counseling ; patient information leaflet (PIL) ; readability assessment ; drug therapy ; knowledge improvement ; Diabetes education

Most Cited Most Cited RSS feed

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error
Please enter a valid_number test