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CompletedNCT00609830Updated Jun 16, 2015

GIOP Prevention Among People With Rheumatoid Arthritis

An interventional study of Tailored Materials and Tailored Materials Plus Physician Feedback in Osteoporosis and Rheumatoid Arthritis, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-16.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
273
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteoporosis
  • Rheumatoid Arthritis

Keywords

  • Glucocorticoids
  • Osteoporosis
  • Rheumatoid Arthritis
  • Prevention
  • GIOP
  • Patient Education
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 273 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Existing osteoporosis
  • Pregnancy
  • Breast feeding
  • History of breast cancer
  • Physician recommendation to limit calcium intake
  • Class IV rheumatoid arthritis
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
273 participants (actual)

Study arms

  • Experimental
    Tailored Materials

    Behavioral: Tailored Materials

  • Experimental
    Physician Feedback

    Behavioral: Tailored Materials Plus Physician Feedback

  • Active comparator
    Generic Materials

    Behavioral: Generic Materials

  • Placebo comparator
    Placebo Comparator

    Participants receive no information

    Behavioral: No Information

Interventions

  • BehavioralTailored 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.

  • BehavioralTailored 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.

  • BehavioralGeneric Materials

    Participants received generic written educational materials about osteoporosis prevention.

  • BehavioralNo Information

    Participants received no informational materials.

06

What researchers measure

Primary outcomes

  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

07

Study locations

1 site
  • University of North Carolina at Chapel Hill School of Pharmacy
    Chapel Hill, North Carolina 27599-7360, United States
08

References and documents

Publications

  • Blalock SJ, Norton LL, Patel RA, Dooley MA. Patient knowledge, beliefs, and behavior concerning the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Rheum. 2005 Oct 15;53(5):732-9. doi: 10.1002/art.21446. PubMed 16208664 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00609830
Lead sponsor
University of North Carolina, Chapel Hill
First posted
Feb 7, 2008
Start date
Jul 2001
Completion
Feb 2006
Last update
Jun 16, 2015

Study contacts

Susan J. Blalock, PhD
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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