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

September 12, 2014 updated by: Spanish Foundation of Rheumatology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Care in the Control Group (CG)
Care in the Control Group (CG): was that provided by the General Practitioners, with basic diagnostic and therapeutic procedures without specified protocols.
Experimental: Early Intervention Programa (IG)
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).
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).

What is the study measuring?

Primary Outcome Measures

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Foundation of Rheumatology

Collaborators

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

Investigators

  • Principal Investigator: Juan A. Jover, MD, PhD, IMSALUD
  • Study Director: Loreto Carmona, MD, PhD, Spanish Foundation of Rheumatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

April 3, 2006

First Submitted That Met QC Criteria

April 3, 2006

First Posted (Estimate)

April 5, 2006

Study Record Updates

Last Update Posted (Estimate)

September 15, 2014

Last Update Submitted That Met QC Criteria

September 12, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI/041582

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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