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Sponsored by: |
University of North Carolina |
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Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00609830 |
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 | Intervention |
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Osteoporosis Rheumatoid Arthritis |
Behavioral: Tailored Materials Behavioral: Tailored Materials Plus Physician Feedback Behavioral: Generic Materials Behavioral: No Information |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Osteoporosis Prevention Among People With Rheumatoid Arthritis Receiving Oral Glucocorticoid Therapy |
Enrollment: | 273 |
Study Start Date: | July 2001 |
Study Completion Date: | February 2006 |
Arms | Assigned Interventions |
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Tailored Materials: Experimental |
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.
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Physician Feedback: Experimental |
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.
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Generic Materials: Active Comparator |
Behavioral: Generic Materials
Participants received generic written educational materials about osteoporosis prevention.
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No Information: No Intervention |
Behavioral: No Information
Participants received no informational materials.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | The University of North Carolina, Chapel Hill |
Responsible Party: | The University of North Carolina at Chapel Hill ( Susan J. Blalock, PhD ) |
Study ID Numbers: | Arthritis Foundation |
Study First Received: | January 24, 2008 |
Last Updated: | January 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00609830 |
Health Authority: | United States: Institutional Review Board |
Glucocorticoids Osteoporosis Rheumatoid Arthritis |
Prevention GIOP Patient Education |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis Connective Tissue Diseases |
Arthritis, Rheumatoid Osteoporosis Bone Diseases, Metabolic Rheumatic Diseases Bone Diseases |
Immune System Diseases |