NCT06235710

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. 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), the investigators use the Pain Assessment Checklist for Seniors with Severe Dementia (PACSLAC-D).
  2. 2.Investigate mobility limitations among nursing home residents.
  3. 3.To understand whether an accurate (differential) diagnosis for the joint complaints is reported in the electronic files.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

September 30, 2025

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

January 23, 2024

Last Update Submit

September 25, 2025

Conditions

Keywords

Rheumatic and musculoskeletal diseasesPrevalenceNursing home residents

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1

Secondary Outcomes (3)

  • The severity of their joint complaints that day.

    Day 1

  • Amount and severity of mobility limitations among nursing home residents.

    Day 1

  • Information on whether an accurate (differential) diagnosis for the joint complaints is reported in the electronic files.

    Day 1

Other Outcomes (1)

  • Additional information collected from the electronic patient files.

    Day 1

Study Arms (2)

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).

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Diagnosis dementia;
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cicero Zorggroep

Brunssum, Limburg, 6440 AC, Netherlands

Location

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MeSH Terms

Conditions

Arthritis, RheumatoidRheumatic DiseasesMusculoskeletal DiseasesGoutJoint DiseasesArthritisMusculoskeletal PainOsteoarthritis

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesCrystal ArthropathiesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesMuscular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marloes van Onna, MD; PhD

    Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 1, 2024

Study Start

January 18, 2024

Primary Completion

March 1, 2025

Study Completion

May 1, 2025

Last Updated

September 30, 2025

Record last verified: 2025-05

Locations