Disability of Musculoskeletal Origin in Community-dwelling Elderly

Not Applicable

Completed

• Conditions: Musculoskeletal Diseases
• Interventions: Procedure: Specific clinical care program

• Registration Number: NCT00311103
• Lead Sponsor: Spanish Foundation of Rheumatology

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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-04-03
• Study First Submitted QC: 2006-04-03
• Study First Posted: 2006-04-05
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-12
• Last Update Posted: 2014-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Intervention Programa (IG)	Specific clinical care program	Early Intervention Programa (IG): Patients assigned to the intervention group after the randomization were offered an immediate appointment. Patients, who voluntarily accepted, were attended by 2 rheumatologists. The rheumatologists acted as principal care providers in regular visits, home visits and phone contacts. The visits were structured following specific proceedings for the different diagnoses based on previously demonstrated approaches. Such protocols included education and promotion of independence, pharmacological and no pharmacological treatment, and timing of diagnostic tests in a stepwise manner. The program also incorporated administrative duties such as the prescription of medication for the patients. Patients were seen as often as necessary according to the medical rheumatologist decision (until the episode of disability was medically resolved).

Primary Outcome Measures

Name	Time	Method
Number of subsequent DIMS	Period of time in days until the patients recovers defined as: an improvement in at least one point in the Rosser disability level
Time to improvement in the baseline recent-onset disability episode of musculoskeletal origin (DIMS)	Period of time in days until the patients recovers defined as: an improvement in at least one point in the Rosser disability level
Total number of DIMS days	Period of time in days until the patients recovers defined as: an improvement in at least one point in the Rosser disability level

Secondary Outcome Measures

Name	Time	Method
Direct and Indirect Costs	Period of time in days until the patients recovers defined as: an improvement in at least one point in the Rosser disability level

Trial Locations

Locations (1)

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain