Prevalence of Musculoskeletal Complaints in Nursing Home Residents

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Jan 23, 2024

Nctid: NCT06235710

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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"}], "primaryOutcomes"=>[{"measure"=>"The prevalence of joint complaints in nursing home residents with and without dementia.", "timeFrame"=>"One-time visit", "description"=>"Our definition of joint complaints is: number of tender and / or swollen joints."}], "secondaryOutcomes"=>[{"measure"=>"The severity of their joint complaints that day.", "timeFrame"=>"One-time visit", "description"=>"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)."}, {"measure"=>"Amount and severity of mobility limitations among nursing home residents.", "timeFrame"=>"One-time", "description"=>"% independent / % cane or walker / % wheelchair / % bedridden / % combination"}, {"measure"=>"Information on whether an accurate (differential) diagnosis for the joint complaints is reported in the electronic files.", "timeFrame"=>"One-time visit", "description"=>"Discrepancy percentage between findings of the musculoskeletal physical examination versus previously recorded findings in the electronic files of the nursing home resident."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Rheumatic and musculoskeletal diseases", "Prevalence", "Nursing home residents"], "conditions"=>["Rheumatoid Arthritis", "Rheumatic Diseases", "Musculoskeletal Diseases", "Musculoskeletal Diseases or Conditions", "Gout", "Degenerative Joint Disease", "Orthopedic Disorder", "Arthritis", "Polyarthritis", "Musculoskeletal Pain", "Arthrosis"]}, "referencesModule"=>{"references"=>[{"pmid"=>"15082494", "type"=>"BACKGROUND", "citation"=>"Abell JE, Hootman JM, Helmick CG. 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Consult Pharm. 2013 Jun;28(6):370-82. doi: 10.4140/TCP.n.2013.370."}]}, "descriptionModule"=>{"briefSummary"=>"The goal of this observational study is to investigate the prevalence of joint complaints in nursing home residents with and without dementia.\n\nPrimary objective: Number of tender or swollen joints.\n\nSecondary objectives:\n\n1. 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).\n2. Investigate mobility limitations among nursing home residents.\n3. To understand whether an accurate (differential) diagnosis for the joint complaints is reported in the electronic files.\n\nDuring 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).\n\nNursing 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.", "detailedDescription"=>"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.\n\nObjectives:\n\nPrimary 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.\n\nSecondary objectives:\n\n1. 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).\n2. Investigate mobility limitations among nursing home residents.\n3. To understand whether an accurate (differential) diagnosis for the joint complaints is reported in the electronic files.\n\nStudy 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.\n\nMain 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).\n\nNursing 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.\n\nExpected outcomes and endpoints:\n\nPrimary outcome: number of nursing home residents, with and without dementia, with joint complaints; average number of painful and number of swollen joints.\n\nSecondary outcomes:\n\n1. 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.\n2. Amount and severity of mobility limitations among nursing home residents (% independent / % cane or walker / % wheelchair / % bedridden / % combination).\n3. 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.\n\nNature 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.\n\nWith regard to participation risks and benefits:\n\nNursing 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.\n\nAbnormalities 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.\n\nPart 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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["OLDER_ADULT"], "minimumAge"=>"65 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"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.\n\nIn 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.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion criteria, group 1:\n\n* Mentally competent nursing home resident ≥ 65 years;\n* No diagnosis of dementia (major neurocognitive disorder according to DSM-5 criteria);\n* The nursing home resident provides informed consent to participate in the study.\n\nInclusion criteria, group 2:\n\n* Nursing home resident with dementia (major neurocognitive disorder according to DSM-5 criteria) ≥ 65 years;\n* The legal representative of the nursing home resident provides informed consent to participate in the study.\n\nExclusion criteria, group 1:\n\n* Diagnosis dementia;\n* Life expectancy \\< 2 weeks (definition terminal nursing home resident). Exclusion criteria, group 2\n* Life expectancy \\< 2 weeks (definition terminal nursing home resident).\n* 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)."}, "identificationModule"=>{"nctId"=>"NCT06235710", "briefTitle"=>"Prevalence of Musculoskeletal Complaints in Nursing Home Residents", "organization"=>{"class"=>"OTHER", "fullName"=>"Maastricht University Medical Center"}, "officialTitle"=>"Prevalence of Musculoskeletal Complaints in Nursing Home Residents", "orgStudyIdInfo"=>{"id"=>"NL84320.068.23"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Group 1: Nursing home residents without dementia", "description"=>"* Mentally competent nursing home resident ≥ 65 years;\n* No diagnosis of dementia (major neurocognitive disorder according to DSM-5 criteria);\n* The nursing home resident provides informed consent to participate in the study.\n\nIn this study, nursing home residents all undergo a physical examination of the musculoskeletal system.\n\nIn addition:\n\n- 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)."}, {"label"=>"Group 2: Nursing home residents with dementia", "description"=>"* Nursing home resident with dementia (major neurocognitive disorder according to DSM-5 criteria) ≥ 65 years;\n* The legal representative of the nursing home resident provides informed consent to participate in the study.\n\nIn this study, nursing home residents all undergo a physical examination of the musculoskeletal system.\n\nIn addition:\n\nIn 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)."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"6440 AC", "city"=>"Brunssum", "state"=>"Limburg", "status"=>"RECRUITING", "country"=>"Netherlands", "contacts"=>[{"name"=>"Shennah Austen, MD", "role"=>"CONTACT", "email"=>"s.austen@cicerozorggroep.nl", "phone"=>"+31(0)455637400"}, {"name"=>"Marloes van Onna, MD; PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Cicero Zorggroep", "geoPoint"=>{"lat"=>50.94667, "lon"=>5.97083}}], "overallOfficials"=>[{"name"=>"Marloes van Onna, MD; PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Maastricht University Medical Centre"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED", "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."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Maastricht University Medical Center", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}