Disability of Musculoskeletal Origin in Community-Dwelling Elderly

This study is currently recruiting participants.

Verified by Spanish Foundation of Rheumatology, April 2006

First Received: April 3, 2006 No Changes Posted

Sponsored by:	Spanish Foundation of Rheumatology
Information provided by:	Spanish Foundation of Rheumatology
ClinicalTrials.gov Identifier:	NCT00311103

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
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

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

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

Keywords provided by Spanish Foundation of Rheumatology:

Elderly
Disability
Musculoskeletal diseases

Study placed in the following topic categories:

Musculoskeletal Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 07, 2009