GIOP Prevention Among People With Rheumatoid Arthritis
|ClinicalTrials.gov Identifier: NCT00609830|
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : June 16, 2015
The ultimate objective of the proposed research is to improve the health-related quality of life of individuals with rheumatoid arthritis by reducing their risk of developing osteoporosis secondary to glucocorticoid therapy. The study has four specific aims.
Specific Aim 1: To obtain descriptive information concerning patients' knowledge, beliefs and behaviors with respect to osteoporosis and osteoporosis prevention.
Specific Aim 2: To identify factors that discriminate among patients in different stages of change with respect to each behavior of interest.
Specific Aim 3: To compare the effects of tailored versus generic educational materials on patient adherence to the ACR Guidelines for the Prevention of Glucocorticoid-Induced Osteoporosis.
Specific Aim 4: To determine if the effects of tailored educational materials are enhanced by concurrent feedback of information concerning patients' behavioral risk factor status to their physicians.
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis Rheumatoid Arthritis||Behavioral: Tailored Materials Behavioral: Tailored Materials Plus Physician Feedback Behavioral: Generic Materials Behavioral: No Information||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||273 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Osteoporosis Prevention Among People With Rheumatoid Arthritis Receiving Oral Glucocorticoid Therapy|
|Study Start Date :||July 2001|
|Actual Study Completion Date :||February 2006|
|Experimental: Tailored Materials||
Behavioral: Tailored Materials
Participants received written educational materials concerning each behavior targeted. The materials were tailored to the participants' stage of change with respect to each behavior.
|Experimental: Physician Feedback||
Behavioral: Tailored Materials Plus Physician Feedback
Participants received written educational materials concerning each behavior targeted. The materials were tailored to the participant's stage of change with respect to each behavior. In additon, the participant's physician received information concerning the participant's status on each behavior targeted.
|Active Comparator: Generic Materials||
Behavioral: Generic Materials
Participants received generic written educational materials about osteoporosis prevention.
Placebo Comparator: Placebo Comparator
Participants receive no information
Behavioral: No Information
Participants received no informational materials.
- Calcium Intake [ Time Frame: One Year ]
- Vitamin D Intake [ Time Frame: One Year ]
- Bone Mineral Density Testing [ Time Frame: One Year ]
- Use of prophylactic medications (e.g., bisphosphonates) [ Time Frame: One Year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00609830
|United States, North Carolina|
|University of North Carolina at Chapel Hill School of Pharmacy|
|Chapel Hill, North Carolina, United States, 27599-7360|
|Principal Investigator:||Susan J. Blalock, PhD||University of North Carolina, Chapel Hill|