NCT00230945

Brief Summary

The purpose of this study is to determine if osteoarthritis patients and their spouses experience greater health benefits from a couples-oriented psychosocial intervention than a patient-oriented psychosocial intervention, and to determine if each intervention is more beneficial than patient usual medical care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
543

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2005

Completed
Last Updated

March 28, 2008

Status Verified

March 1, 2008

Enrollment Period

4.6 years

First QC Date

September 29, 2005

Last Update Submit

March 27, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

  • patient pain, disability, and depressive symptoms. spouse stress and negative affect

    6 months

Secondary Outcomes (1)

  • positive affect, exercise, spousal support and critical attitudes

    6 months

Study Arms (2)

1

EXPERIMENTAL

Patient-oriented education and support intervention

Behavioral: education and support intervention

2

EXPERIMENTAL

Couple-oriented education and support intervention

Behavioral: education and support intervention

Interventions

The patient-oriented education and support intervention (PES) is based on the Arthritis Self-Management Program, a group intervention that consists of 6 weekly 2 hour sessions shown to successfully reduce pain severity and depressive symptomatology and to enhance a sense of efficacy in managing arthritis pain and other symptoms. The couple-oriented education and support intervention (CES) is a group education and support intervention that consisted of 6 weekly 2 hour sessions attended by individuals with OA and their spouses. All components of the PES are covered in the CES using the standard format, and topics are framed as couples' issues whenever possible.

12

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • osteoarthritis in back, hips, and/or knees(patients) married and co-residing age 50 or older pain of at least moderate intensity difficulty with at least one instrumental ADL receiving help from spouse w/ at least one instrumental IADL

You may not qualify if:

  • fibromyalgia or rheumatoid arthritis taken Arthritis Self-Help Course in past 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Educational Status

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Lynn M. Martire, Ph.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2005

First Posted

October 3, 2005

Study Start

January 1, 2000

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

March 28, 2008

Record last verified: 2008-03

Locations