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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot; Foot Ulcer, Diabetic; Educational Intervention; Foot Care; Foot Cellulitis
• Intervention / Treatment: Behavioral: Self-care behavior to promote foot care through educational guidance among individual with diabetes

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75850
      • SINA Mewasha & North Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard care advice; The control group will simply get standard advice from clinicians at the clinic during consultations.
Experimental: standard care advice+ structured training through pictures containing learning pamphlet; 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; Apart from physician consultation, individuals will received structured training of how to care their foot to avoid ulcer and inflammation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Foot Complications	A successful educational intervention will potentially lead to a decrease in foot complications among individuals with Type 2 Diabetes. This will include a reduction in foot ulcers, infections, and amputations, ultimately improving participants' overall quality of life.	3 months
Empowerment and Self-efficacy	Participation in the educational intervention will empower individuals to take greater control of their diabetes management, leading to increased self-efficacy in managing their condition. This will result in improved confidence in their ability to prevent and manage foot complications.	Three months treatment

Collaborators and Investigators

• Sponsor: SINA Health Education and Welfare Trust
• Collaborators: Aga Khan University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Actual): August 15, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: April 7, 2024
• First Submitted That Met QC Criteria: April 7, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 28, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; vulnerable population; low-socioeconomic status; slums population; Diabetes foot care; Knowledge on foot care
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Infections; Inflammation; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Connective Tissue Diseases; Skin Diseases, Infectious; Suppuration; Diabetes Mellitus, Type 2; Diabetic Foot; Foot Ulcer; Cellulitis
• Other Study ID Numbers: 00004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No