Effectiveness of Educational Intervention on Footcare Among Individuals Having Type 2 Diabetes at Slums of Karachi, Pakistan.

NCT06358846 | Completed

• 1 other identifier: 00004
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

There are multiple studies conducted in Pakistan that supports the topic of foot care knowledge among individual with type 2 diabetes but all are descriptive cross-sectional studies and investigators cannot develop cause effect relationship out of it. Secondly, there is a lack of documented research on the foot care knowledge shown by people with T2D residing in the slums of Karachi. In order to assess the knowledge intervention among the individual having T2D through qualified diabetes educators and pictorial educational pamphlet along with the standard care of treatment. Consequently, it may aid in the development of effective methods aimed at mitigating foot-related complications among this specific population. Individuals diagnosed with diabetes are required to engage in proactive and structured self-care activities by providing the foot care knowledge in order to effectively manage their condition and mitigate the risk of potential complications. The incorporation of health-deviation knowledge and activities into routine is crucial.

Conditions

Diabetic Foot; Educational Intervention; Foot Care; Foot Ulcer, Diabetic; Foot Cellulitis

Keywords

Type 2 Diabetes; slums population; vulnerable population; low-socioeconomic status; Diabetes foot care; Knowledge on foot care

Outcome Measures

Primary Outcomes (2)

• Improved Foot Care Knowledge

  One potential outcome will be an increase in knowledge among participants regarding foot care practices specific to managing diabetes. This will include understanding the importance of proper footwear, regular foot inspections, and hygiene practices.

  Time Frame: Three months after patient counselling towards foot care

• Behavior Change

  The educational intervention will lead to positive changes in behavior related to foot care. Participants will be more likely to engage in recommended foot care practices such as daily foot inspections, avoiding walking barefoot, and seeking prompt medical attention for any foot-related issues.

  Time Frame: Three months after patient counselling towards foot care

Secondary Outcomes (2)

• Reduction in Foot Complications

  3 months

• Empowerment and Self-efficacy

  Three months treatment

Study Arms (2)

standard care advice

NO INTERVENTION

The control group will simply get standard advice from clinicians at the clinic during consultations.

standard care advice+ structured training through pictures containing learning pamphlet

EXPERIMENTAL

Interventional group will receive standard advice from clinician along with the structured training from qualified diabetes' educator through pictures containing learning pamphlet

Behavioral: Self-care behavior to promote foot care through educational guidance among individual with diabetes

Interventions

Self-care behavior to promote foot care through educational guidance among individual with diabetes BEHAVIORAL

Apart from physician consultation, individuals will received structured training of how to care their foot to avoid ulcer and inflammation.

standard care advice+ structured training through pictures containing learning pamphlet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients aged 18 years or older.
• Patients who are registered at designated SINA clinic and clinical and biochemical diagnosis of DM for at least six months
• Patients who are able to understand Urdu language will be included in the study
• Patients who are voluntarily participated the study will be included.

You may not qualify if:

• Patients come with recurrent foot ulcers or gangrene.
• History of amputation
• Patient live in other than designated slums location.

Sponsors & Collaborators

• SINA Health Education and Welfare Trust: lead
• Aga Khan University: collaborator

Study Sites (1)

SINA Mewasha & North Clinic

Karachi, Sindh, 75850, Pakistan

Location

Related Publications (1)

• Sharif H, Kadir M, Hashmi M, Naz S, Azam I, Imam A, Masood MQ. Effectiveness of pictorial educational intervention on foot care among individuals having type 2 diabetes at slums of Karachi, Pakistan: asingle blinded randomized control trial. BMC Public Health. 2025 Sep 30;25(1):3214. doi: 10.1186/s12889-025-23969-6.

  PMID: 41029643 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Manager

Model Details: Control arm =75 Interventional arm = 75

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 11, 2024
• Study Start: May 15, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 31, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

PA (1)