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Self-Management of Osteoarthritis (SeMOA)

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ClinicalTrials.gov Identifier: NCT00288912
Recruitment Status : Completed
First Posted : February 8, 2006
Results First Posted : September 12, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition: Osteoarthritis
Interventions: Behavioral: Health Education
Behavioral: Osteoarthritis Self-Management

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began on Oct 3, 2006 and ended on June 30, 2008. We used VA medical records to identify patients with hip and knee OA and no exclusionary diagnoses. We mailed introductory letters to these individuals and followed up with a screening phone call. Eligible patients were asked to come to the Durham VA for a baseline visit.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1

Health Education Intervention

Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.

Arm 2 Usual Medical Care
Arm 3

Osteoarthritis Self-Management

Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.


Participant Flow:   Overall Study
    Arm 1   Arm 2   Arm 3
STARTED   175   174   174 
COMPLETED   158   157   146 
NOT COMPLETED   17   17   28 
Developed exclusion criterion                4                6                7 
Lost to Follow-up                9                6                9 
Withdrawal by Subject                4                5                12 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Among n=523 who consented and were randomized 8 were excluded from analyses because subsequent review of VA medical records revealed there was no documentation of radiographic evidence of knee or hip OA and therefore these participants did not meet initial eligibility requirements.

Reporting Groups
  Description
Arm 1

Health Education Intervention

Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.

Arm 2 Usual Medical Care
Arm 3

Osteoarthritis Self-Management

Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.

Total Total of all reporting groups

Baseline Measures
   Arm 1   Arm 2   Arm 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 172   171   172   515 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.3  (10.8)   59.7  (10.1)   60.3  (10.3)   60.1  (10.4) 
Gender 
[Units: Participants]
       
Female   12   10   15   37 
Male   160   161   157   478 
Race/Ethnicity, Customized 
[Units: Participants]
       
White   91   92   95   278 
Non-White   81   79   77   237 
Region of Enrollment 
[Units: Participants]
       
United States   172   171   172   515 


  Outcome Measures

1.  Primary:   Pain   [ Time Frame: Baseline and 12-month follow-up ]

2.  Secondary:   AIMS 2 Physical Function   [ Time Frame: Baseline and 12-month follow-up ]

3.  Secondary:   AIMS 2 Affect   [ Time Frame: Baseline and 12 months ]

4.  Secondary:   Arthritis Self Efficacy   [ Time Frame: Baseline and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Kelli Allen
Organization: Durham VA HSR&D
phone: 919-286-0411 ext 7090
e-mail: kelli.allen@va.gov


Publications of Results:


Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00288912     History of Changes
Other Study ID Numbers: IIR 04-016
First Submitted: February 6, 2006
First Posted: February 8, 2006
Results First Submitted: August 1, 2014
Results First Posted: September 12, 2014
Last Update Posted: April 24, 2015