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.
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
- Conditions the study is for
- Rheumatoid Arthritis, Rheumatic Diseases, Musculoskeletal Diseases
- 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.
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:
- 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).
- Investigate mobility limitations among nursing home residents.
- 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:
- 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).
- Investigate mobility limitations among nursing home residents.
- 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:
- 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.
- Amount and severity of mobility limitations among nursing home residents (% independent / % cane or walker / % wheelchair / % bedridden / % combination).
- 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.
- Conditions
- Rheumatoid Arthritis, Rheumatic Diseases, Musculoskeletal Diseases, Musculoskeletal Diseases or Conditions, Gout, Degenerative Joint Disease
- 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 group | Role | What 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.
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)
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
Amount and severity of mobility limitations among nursing home residents.
% independent / % cane or walker / % wheelchair / % bedridden / % combination
Measured: Day 1
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.
- First posted1 Feb 2024
- Study start18 Jan 2024
- Primary completion1 Mar 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marloes van Onna, MD; PhD, Principal investigator, Maastricht University Medical Centre
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 15082494Achterberg 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 17616332J. 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 27570449Albertsen 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 34536989Algameel 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 32494264Altiparmak 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 22037245Bekhet 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 25457691Black 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 17132974Boerlage 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 18267371Cook 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 9469172D'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 16556306Damian 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 15324637Decker 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 19481044Ferrell 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Musculoskeletal Complaints in Nursing Home Residents
- ClinicalTrials.gov ID
- NCT06235710
- Acronym / sponsor ID
- NL84320.068.23
- Conditions
- Rheumatoid Arthritis, Rheumatic Diseases, Musculoskeletal Diseases, Musculoskeletal Diseases or Conditions, Gout, Degenerative Joint Disease
- Keywords
- Rheumatic and musculoskeletal diseases, Prevalence, Nursing home residents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 1 Feb 2024 (actual)
- 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.
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:
- 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).
- Investigate mobility limitations among nursing home residents.
- 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.
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:
- 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).
- Investigate mobility limitations among nursing home residents.
- 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:
- 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.
- Amount and severity of mobility limitations among nursing home residents (% independent / % cane or walker / % wheelchair / % bedridden / % combination).
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of joint complaints in nursing home residents with and without dementia.
Time frame: Day 1
Our definition of joint complaints is: number of tender and / or swollen joints.
3 secondary outcomes
The severity of their joint complaints that day.
Time frame: Day 1
Amount and severity of mobility limitations among nursing home residents.
Time frame: Day 1
Information on whether an accurate (differential) diagnosis for the joint complaints is reported in the electronic files.
Time frame: Day 1
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 30 Sep 2025.
- Background: PubMed 15082494Abell 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.
- Background: PubMed 17616332Achterberg 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.
- BackgroundJ. Alaba, E. Arriola, Pain prevalence among the elderly in care homes. Spanish, Revista de la Sociedad Espanola del Dolor 16(6) (2009) 344-351.
- Background: PubMed 27570449Al-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.
- Background: PubMed 34536989Albertsen 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.
- Background: PubMed 32494264Algameel 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.
- Background: PubMed 22037245Altiparmak 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.
- Background: PubMed 25457691Bekhet 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.
- Background: PubMed 17132974Black 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.
- Background: PubMed 18267371Boerlage 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.
- Background: PubMed 9469172Cook 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.
- Background: PubMed 16556306D'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.
- Individual participant dataSharing planned: 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.
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A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
Marloes van Onna, MD; PhD principal investigator
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
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.