Musculoskeletal DiseasesDIMENCT00311103
Disability of Musculoskeletal Origin in Community-dwelling Elderly
A study testing Specific clinical care program in people with Musculoskeletal Diseases, run by Spanish Foundation of Rheumatology at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Specific clinical care program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2005to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- Recent surgery
- Dementia with no family support
- Institutionalized
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Specific clinical care program
- Keywords
- Elderly, Disability, Musculoskeletal diseases
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific clinical care programProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Specific clinical care program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to improvement in the baseline recent-onset disability episode of musculoskeletal origin (DIMS)
Measured: 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
Measured: 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
Measured: 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
Measured: Period of time in days until the patients recovers defined as: an improvement in at least one point in the Rosser disability level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startOct 2005
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Foundation of Rheumatology
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion MAPFRE, Fundación Mutua Madrileña, Instituto de Salud Carlos III, La Caixa Foundation
- Responsible party
- Sponsor
- Investigators
- Juan A. Jover, MD, PhD, Principal investigator, IMSALUDLoreto Carmona, MD, PhD, Study director, Spanish Foundation of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311103
- Sponsor's protocol ID
- PI/041582
- Acronym
- DIME
- Status last verified
- Sep 2014
- First submitted
- 3 Apr 2006
- Last updated
- 15 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25634768
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disability of Musculoskeletal Origin in Community-dwelling Elderly: Efficacy of a Specific Clinical Intervention.
- ClinicalTrials.gov ID
- NCT00311103
- Acronym / sponsor ID
- DIME / PI/041582
- Conditions
- Musculoskeletal Diseases
- Keywords
- Elderly, Disability, Musculoskeletal diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Spanish Foundation of RheumatologyUniversity, hospital or other
- Collaborators
- Fundacion MAPFRE, Fundación Mutua Madrileña, Instituto de Salud Carlos III, La Caixa Foundation
- Study start
- Oct 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 5 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Specific clinical care programEarly 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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Diagnosis of Musculoskeletal disorder
- Older than 64 years
- To have disability measured with a) or b):
- Disability of recent onset:less than three months.(Patiens had a better functional situation before)
Key exclusion criteria (3 listed)
- Recent surgery
- Dementia with no family support
- Institutionalized
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific clinical care programThe 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 or surgery | Early Intervention Programa (IG) |
Primary outcome
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
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
- Derived from this study: PubMed 25634768Abasolo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan A. Jover, MD, PhD principal investigator
IMSALUD
Loreto Carmona, MD, PhD study director
Spanish Foundation of Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific clinical care program in people with Musculoskeletal Diseases, run by Spanish Foundation of Rheumatology at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00311103, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2014.