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

Primary Purpose

Diabetic Peripheral Neuropathy

Status
Unknown status
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Diabetic patients with neuropathy
Sponsored by
Hawler Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetic Peripheral Neuropathy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

    -

Sites / Locations

  • Prof. Kawa DizayeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention Group

Usual care Group

Arm Description

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

The usual care group will be provided the standard medical services

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
November 17, 2017
Last Updated
November 22, 2017
Sponsor
Hawler Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03356041
Brief Title
The Role of a Clinical Pharmacist in Lifestyle Modification in Type 2 Diabetic Patients With Peripheral Neuropathy
Official Title
The Role of a Clinical Pharmacist in Lifestyle Modification
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2017 (Anticipated)
Primary Completion Date
March 16, 2018 (Anticipated)
Study Completion Date
March 23, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
The intervention group will receive the three months' lifestyle modification program by a clinical pharmacist.
Arm Title
Usual care Group
Arm Type
No Intervention
Arm Description
The usual care group will be provided the standard medical services
Intervention Type
Other
Intervention Name(s)
Diabetic patients with neuropathy
Other Intervention Name(s)
Intervention group
Intervention Description
Lifestyle modification will be assessed using summary of diabetes self-care activity
Primary Outcome Measure Information:
Title
Estimating Summary of diabetes self-care activity (SDSCA)
Description
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.
Time Frame
Three months
Title
Adherence to treatment according to Morisky scale
Description
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
Time Frame
Three months
Title
Douleur Neuropathique 4 (DN4), Neuropathic Pain Scale (NPS),
Description
Reduction in the percent of response of patients feeling; electric shock, tingling, and pin needle after the lifestyle modification in the intervention group.
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria 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 Exclusion Criteria: 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. -
Facility Information:
Facility Name
Prof. Kawa Dizaye
City
Erbil
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kawa Dizaye, PhD
Phone
009647504452392
Email
kawa.dizaye@hmu.edu.iq
First Name & Middle Initial & Last Name & Degree
Anfal Al-Mallah, MSc
Phone
009647702080031
Email
anfalalmallah@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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