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

Primary Purpose

Musculoskeletal Diseases

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Specific clinical care program
Sponsored by
Spanish Foundation of Rheumatology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Musculoskeletal Diseases focused on measuring Elderly, Disability, Musculoskeletal diseases

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clínico San Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Care in the Control Group (CG)

Early Intervention Programa (IG)

Arm 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): 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).

Outcomes

Primary Outcome Measures

Time to improvement in the baseline recent-onset disability episode of musculoskeletal origin (DIMS)
Number of subsequent DIMS
Total number of DIMS days

Secondary Outcome Measures

Direct and Indirect Costs

Full Information

First Posted
April 3, 2006
Last Updated
September 12, 2014
Sponsor
Spanish Foundation of Rheumatology
Collaborators
Fundacion MAPFRE, Fundación Mutua Madrileña, Instituto de Salud Carlos III, La Caixa Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00311103
Brief Title
Disability of Musculoskeletal Origin in Community-dwelling Elderly
Acronym
DIME
Official Title
Disability of Musculoskeletal Origin in Community-dwelling Elderly: Efficacy of a Specific Clinical Intervention.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spanish Foundation of Rheumatology
Collaborators
Fundacion MAPFRE, Fundación Mutua Madrileña, Instituto de Salud Carlos III, La Caixa Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases
Keywords
Elderly, Disability, Musculoskeletal diseases

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Care in the Control Group (CG)
Arm Type
No Intervention
Arm Description
Care in the Control Group (CG): was that provided by the General Practitioners, with basic diagnostic and therapeutic procedures without specified protocols.
Arm Title
Early Intervention Programa (IG)
Arm Type
Experimental
Arm 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).
Intervention Type
Procedure
Intervention Name(s)
Specific clinical care program
Intervention Description
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 Outcome Measure Information:
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan A. Jover, MD, PhD
Organizational Affiliation
IMSALUD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Loreto Carmona, MD, PhD
Organizational Affiliation
Spanish Foundation of Rheumatology
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25634768
Citation
Abasolo L, Leon L, Lajas C, Carmona L, Serra JA, Reoyo A, Rodriguez-Rodriguez L, Jover JA; APDE Group. An early intervention program for subacute physical disability related to musculoskeletal diseases in the elderly: a pilot study. Rheumatol Int. 2015 Jul;35(7):1183-91. doi: 10.1007/s00296-015-3223-3. Epub 2015 Jan 30.
Results Reference
derived

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Disability of Musculoskeletal Origin in Community-dwelling Elderly

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