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GIOP Prevention Among People With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00609830
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : June 16, 2015
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill

Study Description
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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.


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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Osteoporosis Prevention Among People With Rheumatoid Arthritis Receiving Oral Glucocorticoid Therapy
Study Start Date : July 2001
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Calcium Intake [ Time Frame: One Year ]
  2. Vitamin D Intake [ Time Frame: One Year ]
  3. Bone Mineral Density Testing [ Time Frame: One Year ]
  4. Use of prophylactic medications (e.g., bisphosphonates) [ Time Frame: One Year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • Existing osteoporosis
  • Pregnancy
  • Breast feeding
  • History of breast cancer
  • Physician recommendation to limit calcium intake
  • Class IV rheumatoid arthritis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00609830


Locations
United States, North Carolina
University of North Carolina at Chapel Hill School of Pharmacy
Chapel Hill, North Carolina, United States, 27599-7360
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Susan J. Blalock, PhD University of North Carolina, Chapel Hill
More Information
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Publications of Results:

Responsible Party: Susan J. Blalock, PhD, The University of North Carolina at Chapel Hill
ClinicalTrials.gov Identifier: NCT00609830     History of Changes
Other Study ID Numbers: Arthritis Foundation
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: January 2008

Keywords provided by University of North Carolina, Chapel Hill:
Glucocorticoids
Osteoporosis
Rheumatoid Arthritis
 Prevention
GIOP
Patient Education

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoporosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
Metabolic Diseases
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs