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

Training Leaflet Clinical Trial

Official title:

The Effect of Group Training on the Quality of Life and Reduction of Pain in Rheumatoid Arthritis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998373
• Other study ID #: 7971
• Status: Completed
• Phase: N/A
• First received: November 18, 2013
• Last updated: November 23, 2013
• Start date: January 2006
• Est. completion date: January 2009

Study information

• Verified date: November 2013
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 34 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Training Leaflet
• Training Workshop

Intervention

Behavioral:
• training leaflet and oral training
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	the rheumatology clinic at Imam Khomeini Hospital in Tehran	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The score of quality of life had significantly improved in the two groups (using questionnaire)		one year	Yes
Secondary	In the present study a greater percentage of patients reported less pain after intervention (using questionnaire)		one year	Yes