Disability of Musculoskeletal Origin in Community-Dwelling Elderly

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Spanish Foundation of Rheumatology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Spanish Foundation of Rheumatology
ClinicalTrials.gov Identifier:
NCT00311103
First received: April 3, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
  Purpose

Objectives: To assess the efficacy of an intervention program targeted to the elderly with recent-onset disability of musculoskeletal origin (DIMS), and to perform its economic evaluation.


Condition Intervention
Musculoskeletal Diseases
Procedure: Specific clinical care program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Disability of Musculoskeletal Origin in Community-Dwelling Elderly: Efficacy of a Specific Clinical Intervention.

Further study details as provided by Spanish Foundation of Rheumatology:

Primary Outcome Measures:
  • Time to improvement in the baseline recent-onset disability episode of musculoskeletal origin (DIMS)
  • Number of subsequent DIMS
  • Total number of DIMS days

Secondary Outcome Measures:
  • Direct and Indirect Costs

Estimated Enrollment: 214
Study Start Date: October 2005
Estimated Study Completion Date: October 2008
Detailed Description:

Methodology: 1) Controlled randomised intervention study (3 years). Subjects: persons older than 65 in health district 7 of Madrid with acute (< 3 months) DIMS. Intervention group patients will be attended by rheumatologists acording with clinical (diagnostic and therapeutical) protocols. Control group will receive the routine attention from the Health System. Efficacy and costs variables will be collected through monthly structured telephone interviews performed by independent personnel blinded to the intervention group. Efficacy will be measured by differences between groups regarding: 1) time to improvement in the baseline DIMS episode, 2) number of subsequent DIMS, and 3) total number of DIMS days. An economic evaluation will be performed from a societal perspective.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Musculoskeletal disorder
  • Older than 64 years
  • To have disability measured with a) or b):

    1. Rosser clasification: at least 4.
    2. M.Gill questionnaire: To need help from other person to dress, to tidy up itself, to walk or to stand up.
  • Disability of recent onset:less than three months.(Patiens had a better functional situation before)

Exclusion Criteria:

  • Recent surgery
  • Dementia with no family support
  • Institutionalized
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311103

Contacts
Contact: Juan A. Jover, MD, PhD +34913303615 jjover.hcsc@salud.madrid.org
Contact: Loreto Carmona, MD, PhD +34915754921 lcarmona@ser.es

Locations
Spain
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Loreto Carmona, MD, PhD    +34915754921    lcarmona@ser.es   
Principal Investigator: Juan a. Jover, MD, PhD         
Sub-Investigator: Jose A Serra, MD, PhD         
Sub-Investigator: Agustin Reoyo, MD, PhD         
Sub-Investigator: Loreto Carmona, MD, PhD         
Sub-Investigator: Lydia Abasolo, MD         
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Loreto Carmona, MD, PhD    +34915754921    lcarmona@ser.es   
Principal Investigator: Juan A Jover, MD, PhD         
Sub-Investigator: Loreto Carmona, MD, PhD         
Sub-Investigator: Jose A. Serra, MD, PhD         
Sub-Investigator: Agustin Reoyo, MD, PhD         
Sub-Investigator: Lydia Abasolo, MD         
Sponsors and Collaborators
Spanish Foundation of Rheumatology
Investigators
Principal Investigator: Juan A. Jover, MD, PhD IMSALUD
Study Director: Loreto Carmona, MD, PhD Spanish Foundation of Rheumatology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00311103     History of Changes
Other Study ID Numbers: PI/041582
Study First Received: April 3, 2006
Last Updated: April 3, 2006
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Spanish Foundation of Rheumatology:
Elderly
Disability
Musculoskeletal diseases

Additional relevant MeSH terms:
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 01, 2014