Disability of Musculoskeletal Origin in Community-dwelling Elderly

Musculoskeletal Diseases Clinical Trial

— DIME  

Official title:

Disability of Musculoskeletal Origin in Community-dwelling Elderly: Efficacy of a Specific Clinical Intervention.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311103
• Other study ID #: PI/041582
• Status: Completed
• Phase: N/A
• First received: April 3, 2006
• Last updated: September 12, 2014
• Start date: October 2005
• Est. completion date: May 2008

Study information

• Verified date: September 2014
• Source: Spanish Foundation of Rheumatology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Musculoskeletal Diseases

Intervention

Procedure:
• Specific clinical care program
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).

Locations

Country	Name	City	State
Spain	Hospital Clínico San Carlos	Madrid

Sponsors (5)

Lead Sponsor	Collaborator
Spanish Foundation of Rheumatology	Fundacion La Caixa, Fundacion MAPFRE, Fundación Mutua Madrileña, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No