The Role of a Clinical Pharmacist in Lifestyle Modification in Type 2 Diabetic Patients With Peripheral Neuropathy

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

The Role of a Clinical Pharmacist in Lifestyle Modification

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03356041
• Other study ID #: Hawler Med University
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2017
• Last updated: November 22, 2017
• Start date: December 20, 2017
• Est. completion date: March 23, 2018

Study information

• Verified date: November 2017
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aims of this study are to determine the prevalence of diabetic peripheral neuropathy among the diabetic patients, to determine the association between the clinical profiles of the diabetic patients (diabetes type, diabetes duration, HbA1c, body mass index, hypertension, total cholesterol) and the diabetic peripheral neuropathy DPN and the rational poly pharmacy used to control pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 23, 2018
• Est. primary completion date: March 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion criteria

1. Aged 18 years or older.

2. Both sex.

3. Diagnosed with type 2 diabetes at least one year previously.

4. Took at least one prescribed medication for diabetes.

5. Diagnosed as diabetic peripheral neuropathy based on clinical

Exclusion Criteria:

1. History of alcohol consumption.

2. Thyroid gland disorder.

3. Any kidney disorder.

4. Any conditions that could confound assessment of pain due to diabetic peripheral neuropathy.

5. Have foot injury or open sore.

6. Pregnant females or who plan to become pregnant during the study period.

7. Any serious medical condition that might prevent completion or hinder compliance with exercise.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• Diabetic patients with neuropathy
Lifestyle modification will be assessed using summary of diabetes self-care activity

Locations

Country	Name	City	State
Iraq	Prof. Kawa Dizaye	Erbil

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimating Summary of diabetes self-care activity (SDSCA)	Assessing Lifestyle modification by summary of diabetes self-care activity (SDSCA) at baseline visit and after three months for both Intervention patients and usual care group Increases in the means of the items of the scale as Exercise, Blood sugar testing, Specific diet and Foot care in the intervention group.	Three months
Primary	Adherence to treatment according to Morisky scale	Morisky scale is used to assess medication adherence at baseline visit and after three months for both Intervention patients and usual care group.; Improving the patient medication adherence behavior in the intervention group patients	Three months
Primary	Douleur Neuropathique 4 (DN4), Neuropathic Pain Scale (NPS),	Reduction in the percent of response of patients feeling; electric shock, tingling, and pin needle after the lifestyle modification in the intervention group.	Three months