NCT00311103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

September 15, 2014

Status Verified

September 1, 2014

Enrollment Period

2.6 years

First QC Date

April 3, 2006

Last Update Submit

September 12, 2014

Conditions

Musculoskeletal Diseases

Keywords

ElderlyDisabilityMusculoskeletal diseases

Outcome Measures

Primary Outcomes (3)

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

    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

    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

    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

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

Study Arms (2)

Care in the Control Group (CG)

NO INTERVENTION

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

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

Interventions

Specific clinical care programPROCEDURE

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).

Early Intervention Programa (IG)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Recent surgery
  • Dementia with no family support
  • Institutionalized

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Related Publications (1)

  • 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.

    PMID: 25634768DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Juan A. Jover, MD, PhD

    IMSALUD

    PRINCIPAL INVESTIGATOR

  • Loreto Carmona, MD, PhD

    Spanish Foundation of Rheumatology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 5, 2006

Study Start

October 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

September 15, 2014

Record last verified: 2014-09

Locations

ES(1)