Prevalence of Musculoskeletal Complaints in Nursing Home Residents

January 23, 2024 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Brunssum, Limburg, Netherlands, 6440 AC
        • Recruiting
        • Cicero Zorggroep
        • Contact:
        • Principal Investigator:
          • Marloes van Onna, MD; PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of joint complaints in nursing home residents with and without dementia.
Time Frame: One-time visit
Our definition of joint complaints is: number of tender and / or swollen joints.
One-time visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The severity of their joint complaints that day.
Time Frame: One-time visit
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
Amount and severity of mobility limitations among nursing home residents.
Time Frame: One-time
% independent / % cane or walker / % wheelchair / % bedridden / % combination
One-time
Information on whether an accurate (differential) diagnosis for the joint complaints is reported in the electronic files.
Time Frame: One-time visit
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional information collected from the electronic patient files.
Time Frame: One-time visit
- 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Marloes van Onna, MD; PhD, Maastricht University Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL84320.068.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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