- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01998373
Group Training and Quality of Life and Reduction of Pain in Rheumatoid Arthritis Patients
The Effect of Group Training on the Quality of Life and Reduction of Pain in Rheumatoid Arthritis Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- the rheumatology clinic at Imam Khomeini Hospital in Tehran
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: patient training and patient without training
Experimental group 1: patient education intervention group (PIGE) Experimental group 2: patient without intervention group (PWIG)
|
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.
Other Names:
|
|
No Intervention: control without education
this group did not receive an education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The score of quality of life had significantly improved in the two groups (using questionnaire)
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
In the present study a greater percentage of patients reported less pain after intervention (using questionnaire)
Time Frame: one year
|
one year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7971
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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