Clinical trial NCT06235710: Prevalence of Musculoskeletal Complaints in Nursing Home Residents
Official title: Prevalence of Musculoskeletal Complaints in Nursing Home Residents
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Rheumatic Diseases
Musculoskeletal Diseases
Musculoskeletal Diseases or Conditions
Gout
Degenerative Joint Disease
Orthopedic Disorder
Arthritis
Polyarthritis
Musculoskeletal Pain
Arthrosis
Keywords: Rheumatic and musculoskeletal diseases
Prevalence
Nursing home residents
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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), we 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), we 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:

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), we 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), we 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.

Eligibility criteria: Inclusion 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.

Inclusion criteria, group 2:

* 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.

Exclusion criteria, group 1:

* Diagnosis dementia;
* Life expectancy \&lt; 2 weeks (definition terminal nursing home resident). Exclusion criteria, group 2
* Life expectancy \&lt; 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).

Primary outcomes:
measure: The prevalence of joint complaints in nursing home residents with and without dementia.
timeFrame: One-time visit
Secondary outcomes:
measure: The severity of their joint complaints that day.
timeFrame: One-time visit
measure: Amount and severity of mobility limitations among nursing home residents.
timeFrame: One-time
measure: Information on whether an accurate (differential) diagnosis for the joint complaints is reported in the electronic files.
timeFrame: One-time visit
Other outcomes:
measure: Additional information collected from the electronic patient files.
timeFrame: One-time visit
Locations:
city: Brunssum
country: Netherlands
facility: Cicero Zorggroep
state: Limburg
Study officials:
affiliation: Maastricht University Medical Centre
name: Marloes van Onna, MD; PhD
role: PRINCIPAL_INVESTIGATOR
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