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

This study has been completed.
Sponsor:
Collaborators:
Fundacion MAPFRE
Fundación Mutua Madrileña
Instituto de Salud Carlos III
Fundacion La Caixa
Information provided by (Responsible Party):
Spanish Foundation of Rheumatology
ClinicalTrials.gov Identifier:
NCT00311103
First received: April 3, 2006
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Musculoskeletal Diseases
Procedure: Specific clinical care program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Disability of Musculoskeletal Origin in Community-dwelling Elderly: Efficacy of a Specific Clinical Intervention.

Further study details as provided by Spanish Foundation of Rheumatology:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 214
Study Start Date: October 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311103

Locations
Spain
Hospital Clínico San Carlos
Madrid, Spain, 28040
Sponsors and Collaborators
Spanish Foundation of Rheumatology
Fundacion MAPFRE
Fundación Mutua Madrileña
Instituto de Salud Carlos III
Fundacion La Caixa
Investigators
Principal Investigator: Juan A. Jover, MD, PhD IMSALUD
Study Director: Loreto Carmona, MD, PhD Spanish Foundation of Rheumatology
  More Information

No publications provided

Responsible Party: Spanish Foundation of Rheumatology
ClinicalTrials.gov Identifier: NCT00311103     History of Changes
Other Study ID Numbers: PI/041582
Study First Received: April 3, 2006
Last Updated: September 12, 2014
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Spanish Foundation of Rheumatology:
Elderly
Disability
Musculoskeletal diseases

Additional relevant MeSH terms:
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 25, 2014