Clinical trial NCT00311103: Disability of Musculoskeletal Origin in Community-dwelling Elderly
Official title: Disability of Musculoskeletal Origin in Community-dwelling Elderly: Efficacy of a Specific Clinical Intervention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Diseases
Keywords: Elderly
Disability
Musculoskeletal diseases
Lead sponsor: Spanish Foundation of Rheumatology
Sponsor class: OTHER
Collaborators: name: Fundacion MAPFRE
name: Fundación Mutua Madrileña
name: Instituto de Salud Carlos III
name: La Caixa Foundation
First posted: 2006-04-05
Enrollment: 214
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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 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

Primary outcomes:
measure: Time to improvement in the baseline recent-onset disability episode of musculoskeletal origin (DIMS)
timeFrame: Period of time in days until the patients recovers defined as: an improvement in at least one point in the Rosser disability level
measure: Number of subsequent DIMS
timeFrame: Period of time in days until the patients recovers defined as: an improvement in at least one point in the Rosser disability level
measure: Total number of DIMS days
timeFrame: Period of time in days until the patients recovers defined as: an improvement in at least one point in the Rosser disability level
Secondary outcomes:
measure: Direct and Indirect Costs
timeFrame: Period of time in days until the patients recovers defined as: an improvement in at least one point in the Rosser disability level
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
affiliation: IMSALUD
name: Juan A. Jover, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spanish Foundation of Rheumatology
name: Loreto Carmona, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Abasolo L, Leon L, Lajas C, Carmona L, Serra JA, Reoyo A, Rodriguez-Rodriguez L, Jover JA; APDE Group. An early intervention program for subacute physical disability related to musculoskeletal diseases in the elderly: a pilot study. Rheumatol Int. 2015 Jul;35(7):1183-91. doi: 10.1007/s00296-015-3223-3. Epub 2015 Jan 30.