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Disability of Musculoskeletal Origin in Community-dwelling Elderly (DIME)

S

Spanish Foundation of Rheumatology

Status

Completed

Conditions

Musculoskeletal Diseases

Treatments

Procedure: Specific clinical care program

Study type

Interventional

Funder types

Other

Identifiers

NCT00311103
PI/041582

Details and patient eligibility

About

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.

Full 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.

Enrollment

214 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

214 participants in 2 patient groups

Care in the Control Group (CG)
No Intervention group
Description:
Care in the Control Group (CG): was that provided by the General Practitioners, with basic diagnostic and therapeutic procedures without specified protocols.
Early Intervention Programa (IG)
Experimental group
Description:
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).
Treatment:
Procedure: Specific clinical care program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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