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OpenTrials
Completed

NCT Number: NCT00311103

Disability of Musculoskeletal Origin in Community-dwelling Elderly

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.

Completed

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Key information

Conditions

Musculoskeletal Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico San Carlos

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Musculoskeletal disorder
  • Older than 64 years
  • To have disability measured with a) or b):
  • Rosser clasification: at least 4.
  • 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

Treatment and study plan

Specific clinical care program

Procedure

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 outcomes

  1. Time to improvement in the baseline recent-onset disability episode of musculoskeletal origin (DIMS)

    Time frame: Period of time in days until the patients recovers defined as: an improvement in at least one point in the Rosser disability level

  2. Number of subsequent DIMS

    Time frame: Period of time in days until the patients recovers defined as: an improvement in at least one point in the Rosser disability level

  3. Total number of DIMS days

    Time frame: 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

  1. Direct and Indirect Costs

    Time frame: Period of time in days until the patients recovers defined as: an improvement in at least one point in the Rosser disability level

Sponsors and collaborators

Lead sponsor

Spanish Foundation of Rheumatology

Other

Collaborators

  • Fundacion MAPFRE
  • Fundación Mutua Madrileña
  • Instituto de Salud Carlos III
  • La Caixa Foundation

Registry information

Official study title

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

Acronym: DIME

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Apr 5, 2006
Registry last updated
Sep 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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