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

November 22, 2017 updated by: Kawa Dizaye, Hawler Medical University

The Role of a Clinical Pharmacist in Lifestyle Modification

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention Group
The intervention group will receive the three months' lifestyle modification program by a clinical pharmacist.
Other: Diabetic patients with neuropathy
Lifestyle modification will be assessed using summary of diabetes self-care activity
Other Names:
  • Intervention group
No Intervention: Usual care Group
The usual care group will be provided the standard medical services

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimating Summary of diabetes self-care activity (SDSCA)
Time Frame: Three months
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
Time Frame: Three months

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),
Time Frame: Three months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hawler Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 20, 2017

Primary Completion (Anticipated)

March 16, 2018

Study Completion (Anticipated)

March 23, 2018

Study Registration Dates

First Submitted

November 17, 2017

First Submitted That Met QC Criteria

November 22, 2017

First Posted (Actual)

November 29, 2017

Study Record Updates

Last Update Posted (Actual)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 22, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hawler Med University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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