Prevalence of Musculoskeletal Complaints in Nursing Home Residents

Rheumatoid Arthritis Clinical Trial

Official title:

Prevalence of Musculoskeletal Complaints in Nursing Home Residents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06235710
• Other study ID #: NL84320.068.23
• Status: Recruiting
• Start date: January 18, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: January 2024
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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 < 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).

Related Conditions & MeSH terms

• Arthritis
• Arthrosis
• Collagen Diseases
• Degenerative Joint Disease
• Gout
• Joint Diseases
• Musculoskeletal Diseases
• Musculoskeletal Diseases or Conditions
• Musculoskeletal Pain
• Orthopedic Disorder
• Osteoarthritis
• Polyarthritis
• Rheumatic Diseases
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Netherlands	Cicero Zorggroep	Brunssum	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

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* Note: There are 48 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Additional information collected from the electronic patient files.	- General information: age, gender, smoking and alcohol consumption. - History, co-morbidity and previous operations. Special attention to RMDs, including fractures. This information will be used to calculate a Charlson comorbidity index and for secondary objective 3. - Only for group 2: type of dementia. - Current medication use. - Weight, height, blood pressure and heart rate. - Nursing home home resident's life course, including information about family, number of children, hobbies, level of education, previous work. - Fall frequency and risk of falling (by checking risk signalling list). - Presence of urinary incontinence, pressure ulcers and blemishes, malnutrition, indications of depression, presence of wounds, use of aids (such as adapted cutlery). - 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 (including sw	One-time visit
Primary	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.	One-time visit
Secondary	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).	One-time visit
Secondary	Amount and severity of mobility limitations among nursing home residents.	% independent / % cane or walker / % wheelchair / % bedridden / % combination	One-time
Secondary	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.	One-time visit