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

NCT03356041 | Unknown DMC

• 1 other identifier: Hawler Med University
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

The intervention group will receive the three months' lifestyle modification program by a clinical pharmacist.

Other: Diabetic patients with neuropathy

Usual care Group

NO INTERVENTION

The usual care group will be provided the standard medical services

Interventions

Diabetic patients with neuropathy OTHER

Lifestyle modification will be assessed using summary of diabetes self-care activity

Also known as: Intervention group

Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 years or older.
• Both sex.
• Diagnosed with type 2 diabetes at least one year previously.
• Took at least one prescribed medication for diabetes.
• Diagnosed as diabetic peripheral neuropathy based on clinical

You may not qualify if:

• History of alcohol consumption.
• Thyroid gland disorder.
• Any kidney disorder.
• Any conditions that could confound assessment of pain due to diabetic peripheral neuropathy.
• Have foot injury or open sore.
• Pregnant females or who plan to become pregnant during the study period.
• Any serious medical condition that might prevent completion or hinder compliance with exercise.

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Prof. Kawa Dizaye

Erbil, Iraq

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pharmacology

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 29, 2017
• Study Start: December 20, 2017
• Primary Completion: March 16, 2018
• Study Completion: March 23, 2018
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

IR (1)