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Rheumatoid ArthritisNCT06235710

Prevalence of Musculoskeletal Complaints in Nursing Home Residents

An observational study of Rheumatoid Arthritis and Rheumatic Diseases, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this observational study is to investigate the prevalence of joint complaints in nursing home residents with and without dementia. Primary objective: Number of tender or swollen joints. Secondary objectives: 1. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
How many people
100 participants
Where
1 siteNetherlands
Study dates
18 Jan 2024to 1 May 2025
Phase
Observational
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
  • Healthy volunteers accepted
  • Older adult

Study population: In total, 50 nursing home residents without dementia (group 1) and 50 nursing home residents with dementia (group 2), ≥ 65 years of age, will be included. In the Cicero Zorggroep nursing homes, residents are comparable to those living in other nursing homes in the Netherlands. They undergo the same assessment and screening (in the case of psychogeriatric care: mainly ZZP 5, and in somatic care mainly ZZP 6). Within Cicero, there are no specialized departments (e.g., for Parkinson's disease or young dementia patients), so each department consists of a representative cross-section of nursing home residents. In our study, we do not differentiate between subgroups, except for gender and the presence of dementia.

Who may be able to join

  • Mentally competent nursing home resident ≥ 65 years;
  • No diagnosis of dementia (major neurocognitive disorder according to DSM-5 criteria);
  • The nursing home resident provides informed consent to participate in the study.
  • Nursing home resident with dementia (major neurocognitive disorder according to DSM-5 criteria) ≥ 65 years;
  • The legal representative of the nursing home resident provides informed consent to participate in the study.

Who cannot join

  • Diagnosis dementia;
  • Life expectancy \< 2 weeks (definition terminal nursing home resident). Exclusion criteria, group 2
  • Life expectancy \< 2 weeks (definition terminal nursing home resident).
  • If, on the basis of an already known pattern of behaviour, it is expected that the potential participant will resist the proposed research (anticipated behaviour).

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Cicero Zorggroep

    Brunssum, Limburg, 6440 AC

Other trials in Netherlands

About this study

The goal of this observational study is to investigate the prevalence of joint complaints in nursing home residents with and without dementia.

Primary objective: Number of tender or swollen joints.

Read more

Secondary objectives:

  1. Only when it is possible for the nursing home resident to provide us this information: how nursing home residents themselves assess the severity of their joint complaints that day (at that time). If the nursing home resident cannot answer this question (reliably), the investigators use the Pain Assessment Checklist for Seniors with Severe Dementia (PACSLAC-D).
  2. Investigate mobility limitations among nursing home residents.
  3. To understand whether an accurate (differential) diagnosis for the joint complaints is reported in the electronic files.

During the study, a standard physical examination of the musculoskeletal system will performed. Nursing home residents allocated in group 1 (no dementia) also provide an answer on 3 non-incriminating questions (severity of joint complaints, pain in general and general health).

Nursing home residents allocated in group 2 (dementia) answer, if possible, 1 non-incriminating question (pain in joints at that moment). These question(s) and the physical examination are also widely used in daily clinical practice. No further incriminating questions or questionnaires will be administered. If the nursing home resident cannot answer this question (reliably), the investigators use the PACSLAC-D.

Read the detailed description

Rationale: In older people, alterations in symptom presentation of Rheumatic and Musculoskeletal Diseases (RMDs), objective signs of disease and presence of co-morbidities can pose diagnostic problems and contribute to both over- and undertreatment of RMDs. This is especially the case in nursing home residents. Insight into the prevalence of RMDs and RMD related pain in nursing home residents is currently low. Early recognition and tailored treatment of RMDs may however prevent further loss of mobility, improve quality of life and the quality of medical care of nursing homes residents.

Objectives:

Primary objective: to investigate the prevalence of joint complaints in nursing home residents with and without dementia (major neurocognitive disorder according to DSM-5 criteria). Our definition of joint complaints is: number of tender and / or swollen joints.

Secondary objectives:

  1. Only when it is possible for the nursing home resident to provide us this information: how nursing home residents themselves assess the severity of their joint complaints that day (at that time). If the nursing home resident cannot answer this question (reliably), the investigators use the Pain Assessment Checklist for Seniors with Severe Dementia (PACSLAC-D).
  2. Investigate mobility limitations among nursing home residents.
  3. To understand whether an accurate (differential) diagnosis for the joint complaints is reported in the electronic files.

Study design: observational study, data collection in nursing home residents. Study population: In total, 50 nursing home residents without dementia (group 1) and 50 nursing home residents with dementia (group 2), ≥ 65 years of age, will be included.

Main study parameters/endpoints: During the study, a standard physical examination of the musculoskeletal system will performed. Nursing home residents allocated in group 1 also provide an answer on 3 non-incriminating questions (severity of joint complaints, pain in general and general health).

Nursing home residents allocated in group 2 answer, if possible, 1 non-incriminating question (pain in joints at that moment). These question(s) and the physical examination are also widely used in daily clinical practice. No further incriminating questions or questionnaires will be administered. If the nursing home resident cannot answer this question (reliably), the investigators use the PACSLAC-D.

Expected outcomes and endpoints:

Primary outcome: number of nursing home residents, with and without dementia, with joint complaints; average number of painful and number of swollen joints.

Secondary outcomes:

  1. The average level of joint pain on that day, determined by a VAS scale (0-10, 0 no joint pain; 10 a lot of joint pain). If the nursing home resident cannot answer this question (reliably), result of the PACSLAC-D.
  2. Amount and severity of mobility limitations among nursing home residents (% independent / % cane or walker / % wheelchair / % bedridden / % combination).
  3. More information on how accurately RMDs are reported in the electronic patient files of the nursing home resident. Discrepancy percentage between findings musculoskeletal physical examination versus previously recorded findings in the electronic patient files.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All measurements are performed by trained clinician-researchers using standardized protocols. All participants need to undergo a physical examination of the musculoskeletal system and answer 1-3 questions. No study-specific blood samples are collected during this study. However, in nursing home residents who are under the care of the Cicero care group, a standard blood sample is taken once to twice a year. The laboratory result of the blood sample (C-reactive protein) within a maximum of 3 months before or after the physical examination is also included in this study.

With regard to participation risks and benefits:

Nursing home residents with and without dementia differ significantly from community-dwelling older adults. Multimorbidity, geriatric syndromes and continuous need for complex care are far more common in nursing home residents. Therefore, recommendations on the diagnosis and management of RMDs and musculoskeletal pain in community-dwelling older adults cannot simply be adopted. Nursing home residents with dementia also clearly differ from residents without dementia. As an example: musculoskeletal symptoms such as rigidity, balance problems or a shuffling gait due to unrelieved pain because of arthritis, might be more common in nursing home residents with dementia. For this reason, it is important that nursing home residents with dementia are also included in our study.

Abnormalities during physical examination of potential clinical importance will always be discussed with the nursing home resident / legal representative and their elderly care physician. Awareness of normally unknown pathology may affect a person's perception of his/her own health condition negatively. On the other hand, detection of for instance arthritis has potentially favourable effects on disease progression and may enable early intervention.

Part of the study participants, i.e. those with dementia in group 2, are mentally incompetent / incapacitated. In the event of clear protest / resistance from a nursing home resident, the physical examination will be discontinued. To determine whether there is any protest / resistance, a person who knows the nursing home resident well is always present during the physical examination. This can be the elderly care physician or a nurse. This person has a good understanding of the pattern of habits and behaviours appropriate to that person.

Keywords
Rheumatic and musculoskeletal diseases, Prevalence, Nursing home residents
Medical subject headings
Arthritis, Rheumatoid, Rheumatic Diseases, Musculoskeletal Diseases, Gout, Joint Diseases, Arthritis, Musculoskeletal Pain, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06235710
Study groupRoleWhat they receive
Group 1: Nursing home residents without dementia* Mentally competent nursing home resident ≥ 65 years; * No diagnosis of dementia (major neurocognitive disorder according to DSM-5 criteria); * The nursing home resident provides informed consent to participate in the study. In this study, nursing home residents all undergo a physical examination of the musculoskeletal system. In addition: - In group 1: nursing home residents provide an answer on 3 non-incriminating questions (assessment general health, severity of joint complaints and pain in general).
Group 2: Nursing home residents with dementia* Nursing home resident with dementia (major neurocognitive disorder according to DSM-5 criteria) ≥ 65 years; * The legal representative of the nursing home resident provides informed consent to participate in the study. In this study, nursing home residents all undergo a physical examination of the musculoskeletal system. In addition: In group 2: if possible, provide an answer on 1 non-incriminating question (severity of joint complaints). If the nursing home resident cannot answer this question (reliably), we use the Pain Assessment Checklist for Seniors with Severe Dementia (PACSLAC-D).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The prevalence of joint complaints in nursing home residents with and without dementia.

    Our definition of joint complaints is: number of tender and / or swollen joints.

    Measured: Day 1

Secondary outcomes (3)
  1. The severity of their joint complaints that day.

    the average level of joint pain on that day, determined by a VAS scale (0-10, 0 no joint pain; 10 a lot of joint pain). If the nursing home resident cannot answer this question (reliably), we use the Pain Assessment Checklist for Seniors with Severe Dementia (PACSLAC-D).

    Measured: Day 1

  2. Amount and severity of mobility limitations among nursing home residents.

    % independent / % cane or walker / % wheelchair / % bedridden / % combination

    Measured: Day 1

  3. Information on whether an accurate (differential) diagnosis for the joint complaints is reported in the electronic files.

    Discrepancy percentage between findings of the musculoskeletal physical examination versus previously recorded findings in the electronic files of the nursing home resident.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2024
  2. Study start18 Jan 2024
  3. Primary completion1 Mar 2025
  4. Study completion1 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06235710
Sponsor's protocol ID
NL84320.068.23
Status last verified
May 2025
First submitted
23 Jan 2024
Last updated
30 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: I have not yet chosen a metadata scheme. I will make the following endproducts avaiable for further research and verification: raw data, data documentation, documentation of the research process, including documentation of all participants and syntaxes.

Publications

  • Abell JE, Hootman JM, Helmick CG. Prevalence and impact of arthritis among nursing home residents. Ann Rheum Dis. 2004 May;63(5):591-4. doi: 10.1136/ard.2003.015479.

    PubMed 15082494
  • Achterberg WP, Pot AM, Scherder EJ, Ribbe MW. Pain in the nursing home: assessment and treatment on different types of care wards. J Pain Symptom Manage. 2007 Nov;34(5):480-7. doi: 10.1016/j.jpainsymman.2006.12.017. Epub 2007 Jul 5.

    PubMed 17616332
  • J. Alaba, E. Arriola, Pain prevalence among the elderly in care homes. Spanish, Revista de la Sociedad Espanola del Dolor 16(6) (2009) 344-351.

  • Al-Momani M, Al-Momani F, Alghadir AH, Alharethy S, Gabr SA. Factors related to gait and balance deficits in older adults. Clin Interv Aging. 2016 Aug 9;11:1043-9. doi: 10.2147/CIA.S112282. eCollection 2016.

    PubMed 27570449
  • Albertsen N, Olsen TM, Sommer TG, Prischl A, Kallerup H, Andersen S. Who lives in care homes in Greenland? A nationwide survey of demographics, functional level, medication use and comorbidities. BMC Geriatr. 2021 Sep 18;21(1):500. doi: 10.1186/s12877-021-02442-0.

    PubMed 34536989
  • Algameel M. Patterns of medication use and adherence to medications among residents in the elderly homes. Pak J Med Sci. 2020 May-Jun;36(4):729-734. doi: 10.12669/pjms.36.4.1923.

    PubMed 32494264
  • Altiparmak S, Altiparmak O. Drug-using behaviors of the elderly living in nursing homes and community-dwellings in Manisa, Turkey. Arch Gerontol Geriatr. 2012 Mar-Apr;54(2):e242-8. doi: 10.1016/j.archger.2011.09.014. Epub 2011 Oct 29.

    PubMed 22037245
  • Bekhet AK, Zauszniewski JA. Chronic conditions in elders in assisted living facilities: associations with daily functioning, self-assessed health, and depressive symptoms. Arch Psychiatr Nurs. 2014 Dec;28(6):399-404. doi: 10.1016/j.apnu.2014.08.013. Epub 2014 Sep 3.

    PubMed 25457691
  • Black BS, Finucane T, Baker A, Loreck D, Blass D, Fogarty L, Phillips H, Hovanec L, Steele C, Rabins PV. Health problems and correlates of pain in nursing home residents with advanced dementia. Alzheimer Dis Assoc Disord. 2006 Oct-Dec;20(4):283-90. doi: 10.1097/01.wad.0000213854.04861.cc.

    PubMed 17132974
  • Boerlage AA, van Dijk M, Stronks DL, de Wit R, van der Rijt CC. Pain prevalence and characteristics in three Dutch residential homes. Eur J Pain. 2008 Oct;12(7):910-6. doi: 10.1016/j.ejpain.2007.12.014. Epub 2008 Feb 11.

    PubMed 18267371
  • Cook AJ. Cognitive-behavioral pain management for elderly nursing home residents. J Gerontol B Psychol Sci Soc Sci. 1998 Jan;53(1):P51-9. doi: 10.1093/geronb/53b.1.p51.

    PubMed 9469172
  • D'Astolfo CJ, Humphreys BK. A record review of reported musculoskeletal pain in an Ontario long term care facility. BMC Geriatr. 2006 Mar 23;6:5. doi: 10.1186/1471-2318-6-5.

    PubMed 16556306
  • Damian J, Valderrama-Gama E, Rodriguez-Artalejo F, Martin-Moreno JM. [Health and functional status among elderly individuals living in nursing homes in Madrid]. Gac Sanit. 2004 Jul-Aug;18(4):268-74. doi: 10.1016/s0213-9111(04)72013-0. Spanish.

    PubMed 15324637
  • Decker SA, Culp KR, Cacchione PZ. Evaluation of musculoskeletal pain management practices in rural nursing homes compared with evidence-based criteria. Pain Manag Nurs. 2009 Jun;10(2):58-64. doi: 10.1016/j.pmn.2008.02.008. Epub 2008 Nov 7.

    PubMed 19481044
  • Ferrell BA, Ferrell BR, Osterweil D. Pain in the nursing home. J Am Geriatr Soc. 1990 Apr;38(4):409-14. doi: 10.1111/j.1532-5415.1990.tb03538.x.

    PubMed 2109765

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis and Rheumatic Diseases, run by Maastricht University Medical Center at 1 site in Netherlands.

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 5 inclusion and 4 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 30 Sep 2025. 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 Netherlands. 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?

The prevalence of joint complaints in nursing home residents with and without dementia. (time frame: Day 1). 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 NCT06235710, which also lists 48 linked publications.

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 30 Sep 2025.

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