GIOP Prevention Among People With Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Osteoporosis; Rheumatoid Arthritis
• Interventions: Behavioral: Tailored Materials Plus Physician Feedback; Behavioral: Tailored Materials; Behavioral: Generic Materials; Behavioral: No Information

• Registration Number: NCT00609830
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

Therapy with oral glucocorticoids often plays an important role in the management of rheumatoid arthritis (RA). The American College of Rheumatology (ACR) Ad Hoc Committee on Clinical Guidelines recently concluded that glucocorticoids are highly effective in relieving symptoms among people with active RA and that these medications may retard the rate of joint damage. Despite these obvious benefits, therapy with oral glucocorticoids is a well-established risk factor for osteoporosis, as highlighted by the recently published ACR Guidelines on the Prevention of Glucocorticoid-induced Osteoporosis. The ultimate objective of the proposed research is to improve the health-related quality of life of individuals with RA by reducing their risk of developing osteoporosis secondary to glucocorticoid therapy. The study has four specific aims: (1) to obtain descriptive information concerning patients' knowledge, beliefs and behaviors with respect to osteoporosis and osteoporosis prevention; (2) to identify factors that discriminate among patients in different stages of change with respect to each behavior of interest; (3) to compare the effects of tailored versus generic educational materials on patient adherence to the ACR Guidelines for the Prevention Glucocorticoid-induced Osteoporosis; and (4) to determine if the effects of tailored educational materials is enhanced by concurrent feedback of information concerning patients' behavioral risk factor status to their physicians. A sample of 273 patients with RA currently taking an oral glucocorticoid were recruited to participate in the study. Data were collected via mailed questionnaires and telephone interviews. The study used an experimental research design. Following baseline data collection, participants were randomly assigned to one of four experimental groups. Patients in one group received standard care only. Patients in the second group received generic educational materials about osteoporosis and osteoporosis prevention in addition to standard care. Patients in the third group received educational materials tailored to their stage in the behavior change process in addition to standard care. Finally, patients in the fourth group received the same tailored educational materials and care received by patients in the third group. In addition, each patient's physician received feedback concerning the patient's status with respect to behavioral risk factors for osteoporosis (e.g., inadequate calcium intake). Follow-up data were collected one year after baseline data collection. Variables assessed included: (1) behavior, (2) stage of change, (3) knowledge and counseling received concerning osteoporosis, (4) health beliefs, (5) physical health status, (6) osteoporosis risk factors, (7) background characteristics, and (8) information seeking. To accomplish the specific aims of the study, data will be analyzed using descriptive statistics, multivariate analysis of variance, and discriminant analyses.

Study Timeline

• Study Start: 2001-07
• Study Completion: 2006-02
• Status Verified: 2008-01
• Study First Submitted: 2008-01-24
• Study First Submitted QC: 2008-01-24
• Study First Posted: 2008-02-07
• Last Update Submitted: 2015-06-12
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

Inclusion Criteria

• Meet American College of Rheumatology criteria for rheumatoid arthritis
• Taking an oral glucocorticoid equivalent to 5 mg/day of prednisone for at least one month prior to study entry
• Age 18 or older

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Exclusion Criteria

• Existing osteoporosis
• Pregnancy
• Breast feeding
• History of breast cancer
• Physician recommendation to limit calcium intake
• Class IV rheumatoid arthritis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physician Feedback	Tailored Materials Plus Physician Feedback	-
Tailored Materials	Tailored Materials	-
Generic Materials	Generic Materials	-
Placebo Comparator	No Information	Participants receive no information

Primary Outcome Measures

Name	Time	Method
Calcium Intake	One Year
Vitamin D Intake	One Year
Bone Mineral Density Testing	One Year
Use of prophylactic medications (e.g., bisphosphonates)	One Year

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill School of Pharmacy; 🇺🇸 Chapel Hill, North Carolina, United States