An observational study in Rheumatoid Arthritis, Rheumatic Diseases and Musculoskeletal Diseases, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by Maastricht University Medical Center · Observational
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:
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.
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:
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:
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.
2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.
This study's enrollment of 100 is below the median of 176 across 824 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
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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.
Inclusion criteria, group 1:
Inclusion criteria, group 2:
Exclusion criteria, group 1:
* 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).
* 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).
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.
Time frame: Day 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).
Time frame: Day 1
Amount and severity of mobility limitations among nursing home residents.
% independent / % cane or walker / % wheelchair / % bedridden / % combination
Time frame: 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.
Time frame: Day 1
Additional information collected from the electronic patient files.
* General information: age (years), gender, smoking and alcohol consumption. * History, co-morbidity and previous operations. Special attention to RMDs, including fractures. * Charlson comorbidity index. * Only for group 2: type of dementia. * Current medication use. * Weight (kg), height (cm), blood pressure (mmHg) and heart rate. * Fall frequency (falls/year) * Information on activities of Daily Living (ADL) extracted from the care plan, with information about getting in and out of bed, dressing and undressing, eating and drinking.
Time frame: Day 1
Plan to share: 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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Maastricht University Medical Center