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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06358846
• Other study ID #: 00004
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: SINA Health Education and Welfare Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 31, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cellulitis
• Diabetes Mellitus, Type 2
• Diabetic Foot
• Foot Care
• Foot Ulcer
• Foot Ulcer, Diabetic

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SINA Health Education and Welfare Trust	Aga Khan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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