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Group Training and Quality of Life and Reduction of Pain in Rheumatoid Arthritis Patients

Primary Purpose

Training Leaflet, Training Workshop

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
training leaflet and oral training
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Training Leaflet focused on measuring Patient training, Rheumatoid arthritis, Quality of life

Eligibility Criteria

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

Inclusion Criteria:

  • The only inclusion criterion was that the patient had RA as the main disease (with the same duration and severity of disease).

Exclusion Criteria:

  • Patients were excluded if they had another disease.

Sites / Locations

  • the rheumatology clinic at Imam Khomeini Hospital in Tehran

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

patient training and patient without training

control without education

Arm Description

Experimental group 1: patient education intervention group (PIGE) Experimental group 2: patient without intervention group (PWIG)

this group did not receive an education

Outcomes

Primary Outcome Measures

The score of quality of life had significantly improved in the two groups (using questionnaire)

Secondary Outcome Measures

In the present study a greater percentage of patients reported less pain after intervention (using questionnaire)

Full Information

First Posted
November 18, 2013
Last Updated
November 23, 2013
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01998373
Brief Title
Group Training and Quality of Life and Reduction of Pain in Rheumatoid Arthritis Patients
Official Title
The Effect of Group Training on the Quality of Life and Reduction of Pain in Rheumatoid Arthritis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Abstract Background: It is documented that some patient education interventions, preferably with a behavioral component included, may improve pain, disability and moods Purpose of the study: the purpose of this study was to improve the quality of life and reduce pain in rheumatoid arthritis patients. Methods: Patients were allocated to a patient training intervention group and patient without training intervention group. Both groups received routine treatments while the patient training intervention group, in addition to the routine treatments received training booklets and participated in the training workshop. All the extracted data from the written questionnaire were collected and analyzed using SPSS software.
Detailed Description
Results: The improvement in the signs of recovery for physical and mood symptoms in the patient training intervention group were seen (p < 0.05). The score of quality of life had significantly improved in the two groups (Mean difference was 9.31±3.03 and P<0.003). This improvement was significantly higher in the patient training intervention group (P=0.008). After adjustment for education level, the score of quality of life in patient training intervention group had a higher improvement, but the difference between the two groups was not significant (P = 0.1). Conclusions: This study showed the important role of training and the patients' educational level on better treatments. The appropriate training in the patient could create a change in the treatment process and has a better effect on quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Training Leaflet, Training Workshop
Keywords
Patient training, Rheumatoid arthritis, Quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patient training and patient without training
Arm Type
Experimental
Arm Description
Experimental group 1: patient education intervention group (PIGE) Experimental group 2: patient without intervention group (PWIG)
Arm Title
control without education
Arm Type
No Intervention
Arm Description
this group did not receive an education
Intervention Type
Behavioral
Intervention Name(s)
training leaflet and oral training
Other Intervention Name(s)
education, training workshop
Intervention Description
The intervention consisted of training leaflet and oral training. All of the patients were new cases and were divided into 2 groups. All patients were treated with routine medication, no addition medication for two groups were done, the case group attended the workshops and were trained In addition to medical therapy, continuing education and training workshop. The result of the effect of workshop was also filling out a questionnaire before and after training. Finally, two groups with statistical analysis were compared.
Primary Outcome Measure Information:
Title
The score of quality of life had significantly improved in the two groups (using questionnaire)
Time Frame
one year
Secondary Outcome Measure Information:
Title
In the present study a greater percentage of patients reported less pain after intervention (using questionnaire)
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
34 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The only inclusion criterion was that the patient had RA as the main disease (with the same duration and severity of disease). Exclusion Criteria: Patients were excluded if they had another disease.
Facility Information:
Facility Name
the rheumatology clinic at Imam Khomeini Hospital in Tehran
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Group Training and Quality of Life and Reduction of Pain in Rheumatoid Arthritis Patients

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