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, 

References & Publications (48)

A. Marques, V. Rocha, M. Pinto, L. Sousa, D. Figueiredo, Comorbidities and medication intake among people with dementia living in long-term care facilities, Revista Portuguesa de Saude Publica 33(1) (2015) 42-48.

A.K. Sigurdardottir, K. Olafsson, R.H. Arnardottir, I. Hjaltadottir, Health status and functional profile at admission to nursing homes a population based study over the years 2003-2014: Comparison between people with and without diabetes, Journal of Gerontology and Geriatrics 66(3) (2018) 134-141.

Abell JE, Hootman JM, Helmick CG. Prevalence and impact of arthritis among nursing home residents. Ann Rheum Dis. 2004 May;63(5):591-4. doi: 10.1136/ard.2003.015479. — View Citation

Achterberg WP, Pot AM, Scherder EJ, Ribbe MW. Pain in the nursing home: assessment and treatment on different types of care wards. J Pain Symptom Manage. 2007 Nov;34(5):480-7. doi: 10.1016/j.jpainsymman.2006.12.017. Epub 2007 Jul 5. — View Citation

Al-Momani M, Al-Momani F, Alghadir AH, Alharethy S, Gabr SA. Factors related to gait and balance deficits in older adults. Clin Interv Aging. 2016 Aug 9;11:1043-9. doi: 10.2147/CIA.S112282. eCollection 2016. — View Citation

Albertsen N, Olsen TM, Sommer TG, Prischl A, Kallerup H, Andersen S. Who lives in care homes in Greenland? A nationwide survey of demographics, functional level, medication use and comorbidities. BMC Geriatr. 2021 Sep 18;21(1):500. doi: 10.1186/s12877-021-02442-0. — View Citation

Algameel M. Patterns of medication use and adherence to medications among residents in the elderly homes. Pak J Med Sci. 2020 May-Jun;36(4):729-734. doi: 10.12669/pjms.36.4.1923. — View Citation

Altiparmak S, Altiparmak O. Drug-using behaviors of the elderly living in nursing homes and community-dwellings in Manisa, Turkey. Arch Gerontol Geriatr. 2012 Mar-Apr;54(2):e242-8. doi: 10.1016/j.archger.2011.09.014. Epub 2011 Oct 29. — View Citation

Bekhet AK, Zauszniewski JA. Chronic conditions in elders in assisted living facilities: associations with daily functioning, self-assessed health, and depressive symptoms. Arch Psychiatr Nurs. 2014 Dec;28(6):399-404. doi: 10.1016/j.apnu.2014.08.013. Epub 2014 Sep 3. — View Citation

Black BS, Finucane T, Baker A, Loreck D, Blass D, Fogarty L, Phillips H, Hovanec L, Steele C, Rabins PV. Health problems and correlates of pain in nursing home residents with advanced dementia. Alzheimer Dis Assoc Disord. 2006 Oct-Dec;20(4):283-90. doi: 10.1097/01.wad.0000213854.04861.cc. — View Citation

Boerlage AA, van Dijk M, Stronks DL, de Wit R, van der Rijt CC. Pain prevalence and characteristics in three Dutch residential homes. Eur J Pain. 2008 Oct;12(7):910-6. doi: 10.1016/j.ejpain.2007.12.014. Epub 2008 Feb 11. — View Citation

Cook AJ. Cognitive-behavioral pain management for elderly nursing home residents. J Gerontol B Psychol Sci Soc Sci. 1998 Jan;53(1):P51-9. doi: 10.1093/geronb/53b.1.p51. — View Citation

D'Astolfo CJ, Humphreys BK. A record review of reported musculoskeletal pain in an Ontario long term care facility. BMC Geriatr. 2006 Mar 23;6:5. doi: 10.1186/1471-2318-6-5. — View Citation

Damian J, Valderrama-Gama E, Rodriguez-Artalejo F, Martin-Moreno JM. [Health and functional status among elderly individuals living in nursing homes in Madrid]. Gac Sanit. 2004 Jul-Aug;18(4):268-74. doi: 10.1016/s0213-9111(04)72013-0. Spanish. — View Citation

Decker SA, Culp KR, Cacchione PZ. Evaluation of musculoskeletal pain management practices in rural nursing homes compared with evidence-based criteria. Pain Manag Nurs. 2009 Jun;10(2):58-64. doi: 10.1016/j.pmn.2008.02.008. Epub 2008 Nov 7. — View Citation

Ferrell BA, Ferrell BR, Osterweil D. Pain in the nursing home. J Am Geriatr Soc. 1990 Apr;38(4):409-14. doi: 10.1111/j.1532-5415.1990.tb03538.x. — View Citation

Fisher SE, Burgio LD, Thorn BE, Allen-Burge R, Gerstle J, Roth DL, Allen SJ. Pain assessment and management in cognitively impaired nursing home residents: association of certified nursing assistant pain report, Minimum Data Set pain report, and analgesic medication use. J Am Geriatr Soc. 2002 Jan;50(1):152-6. doi: 10.1046/j.1532-5415.2002.50021.x. — View Citation

Gerber AM, Botes R, Mostert A, Vorster A, Buskens E. A cohort study of elderly people in Bloemfontein, South Africa, to determine health-related quality of life and functional abilities. S Afr Med J. 2016 Feb 4;106(3):298-301. doi: 10.7196/SAMJ.2016.v106i3.10171. — View Citation

Gill TK, Caughey GE, Wesselingh S, Inacio MC. Impact of musculoskeletal conditions among those in residential aged care in Australia. Australas J Ageing. 2022 Mar;41(1):e41-e49. doi: 10.1111/ajag.13001. Epub 2021 Oct 5. — View Citation

Grimby C, Fastbom J, Forsell Y, Thorslund M, Claesson CB, Winblad B. Musculoskeletal pain and analgesic therapy in a very old population. Arch Gerontol Geriatr. 1999 Jul-Aug;29(1):29-43. doi: 10.1016/s0167-4943(99)00021-7. — View Citation

Guccione AA, Meenan RF, Anderson JJ. Arthritis in nursing home residents. A validation of its prevalence and examination of its impact on institutionalization and functional status. Arthritis Rheum. 1989 Dec;32(12):1546-53. doi: 10.1002/anr.1780321208. — View Citation

Hillen JB, Vitry A, Caughey GE. Disease burden, comorbidity and geriatric syndromes in the Australian aged care population. Australas J Ageing. 2017 Jun;36(2):E14-E19. doi: 10.1111/ajag.12411. Epub 2017 Apr 11. — View Citation

Hsieh SW, Huang LC, Hsieh TJ, Lin CF, Hsu CC, Yang YH. Behavioral and psychological symptoms in institutional residents with dementia in Taiwan. Geriatr Gerontol Int. 2021 Aug;21(8):718-724. doi: 10.1111/ggi.14220. Epub 2021 Jun 28. — View Citation

J. Alaba, E. Arriola, Pain prevalence among the elderly in care homes. Spanish, Revista de la Sociedad Espanola del Dolor 16(6) (2009) 344-351.

Jerez-Roig J, Souza DL, Andrade FL, Lima BF Filho, Medeiros RJ, Oliveira NP, Cabral SM Neto, Lima KC. Self-perceived health in institutionalized elderly. Cien Saude Colet. 2016 Nov;21(11):3367-3375. doi: 10.1590/1413-812320152111.15562015. English, Portuguese. — View Citation

Kalideen L, Van Wyk JM, Govender P. Demographic and clinical profiles of residents in long-term care facilities in South Africa: A cross-sectional survey. Afr J Prim Health Care Fam Med. 2022 Mar 18;14(1):e1-e9. doi: 10.4102/phcfm.v14i1.3131. — View Citation

Lapane KL, Quilliam BJ, Chow W, Kim M. The association between pain and measures of well-being among nursing home residents. J Am Med Dir Assoc. 2012 May;13(4):344-9. doi: 10.1016/j.jamda.2011.01.007. Epub 2011 Mar 23. — View Citation

Lind KE, Raban MZ, Brett L, Jorgensen ML, Georgiou A, Westbrook JI. Measuring the prevalence of 60 health conditions in older Australians in residential aged care with electronic health records: a retrospective dynamic cohort study. Popul Health Metr. 2020 Oct 8;18(1):25. doi: 10.1186/s12963-020-00234-z. — View Citation

Luque Ramos A, Albrecht K, Zink A, Hoffmann F. Rheumatologic care of nursing home residents with rheumatoid arthritis: a comparison of the year before and after nursing home admission. Rheumatol Int. 2017 Dec;37(12):2059-2064. doi: 10.1007/s00296-017-3791-5. Epub 2017 Aug 18. — View Citation

Martinez-Gallardo Prieto L, Hermida Galindo LF, D'hyver de Las Deses C. [Prevalence of foot conditions in a geriatric population and their impact on mobility, gait and tendency to falls]. Rev Esp Geriatr Gerontol. 2012 Jan-Feb;47(1):19-22. doi: 10.1016/j.regg.2011.05.004. Epub 2011 Oct 14. Spanish. — View Citation

Monroe T, Carter M, Parish A. A case study using the beers list criteria to compare prescribing by family practitioners and geriatric specialists in a rural nursing home. Geriatr Nurs. 2011 Sep-Oct;32(5):350-6. doi: 10.1016/j.gerinurse.2011.07.003. — View Citation

Moore KL, Boscardin WJ, Steinman MA, Schwartz JB. Age and sex variation in prevalence of chronic medical conditions in older residents of U.S. nursing homes. J Am Geriatr Soc. 2012 Apr;60(4):756-64. doi: 10.1111/j.1532-5415.2012.03909.x. Epub 2012 Mar 29. — View Citation

Ng R, Lane N, Tanuseputro P, Mojaverian N, Talarico R, Wodchis WP, Bronskill SE, Hsu AT. Increasing Complexity of New Nursing Home Residents in Ontario, Canada: A Serial Cross-Sectional Study. J Am Geriatr Soc. 2020 Jun;68(6):1293-1300. doi: 10.1111/jgs.16394. Epub 2020 Mar 2. — View Citation

Nguyen AD, Lind KE, Day RO, Georgiou A, Westbrook JI. A profile of health status and demographics of aged care facility residents with gout. Australas J Ageing. 2020 Mar;39(1):e153-e161. doi: 10.1111/ajag.12716. Epub 2019 Aug 21. — View Citation

Peng LN, Lin MH, Lai HY, Hwang SJ, Chen LK, Lan CF. Pain and health-care utilization among older men in a veterans care home. Arch Gerontol Geriatr. 2009 Dec;49 Suppl 2:S13-6. doi: 10.1016/S0167-4943(09)70006-8. — View Citation

Proctor WR, Hirdes JP. Pain and cognitive status among nursing home residents in Canada. Pain Res Manag. 2001 Fall;6(3):119-25. doi: 10.1155/2001/978130. — View Citation

R. Karmel, D. Gibson, P. Anderson, Y. Wells, S. Duckett, Care trajectories through community and residential aged care services: disease effects, Ageing & Society 32 (2012) 1428-1445.

Sawyer P, Lillis JP, Bodner EV, Allman RM. Substantial daily pain among nursing home residents. J Am Med Dir Assoc. 2007 Mar;8(3):158-65. doi: 10.1016/j.jamda.2006.12.030. — View Citation

Takai Y, Yamamoto-Mitani N, Fukahori H, Kobayashi S, Chiba Y. Nursing ward managers' perceptions of pain prevalence at the aged-care facilities in Japan: a nationwide survey. Pain Manag Nurs. 2013 Sep;14(3):e59-66. doi: 10.1016/j.pmn.2011.04.004. Epub 2011 Jun 17. — View Citation

Tansug M, Kahraman T, Genc A. Differences in Pain Characteristics and Functional Associations between Nursing Home Residents and Community-Dwelling Older Adults: A Cross-Sectional Study. Ann Geriatr Med Res. 2021 Sep;25(3):187-196. doi: 10.4235/agmr.21.0066. Epub 2021 Aug 26. — View Citation

Torvik K, Kaasa S, Kirkevold O, Rustoen T. Pain and quality of life among residents of Norwegian nursing homes. Pain Manag Nurs. 2010 Mar;11(1):35-44. doi: 10.1016/j.pmn.2009.01.001. Epub 2009 Dec 30. — View Citation

Tsai YF, Tsai HH, Lai YH, Chu TL. Pain prevalence, experiences and management strategies among the elderly in taiwanese nursing homes. J Pain Symptom Manage. 2004 Dec;28(6):579-84. doi: 10.1016/j.jpainsymman.2004.03.007. — View Citation

Tse MM, Pun SP, Benzie IF. Pain relief strategies used by older people with chronic pain: an exploratory survey for planning patient-centred intervention. J Clin Nurs. 2005 Mar;14(3):315-20. doi: 10.1111/j.1365-2702.2004.00976.x. — View Citation

U.H. Finne-Soveri, G. Ljunggren, M. Schroll, P.V. Jonsson, I. Hjaltadottir, K. El Kholy, R.S. Tilvis, Pain and its association with disability in institutional long-term care in four Nordic countries, Canadian Journal on Aging 19(SUPPL. 2) (2000) 38-49.

Van Rensbergen G, Nawrot T. Medical conditions of nursing home admissions. BMC Geriatr. 2010 Jul 14;10:46. doi: 10.1186/1471-2318-10-46. — View Citation

Veal F, Williams M, Bereznicki L, Cummings E, Winzenberg T. A retrospective review of pain management in Tasmanian residential aged care facilities. BJGP Open. 2019 Mar 6;3(1):bjgpopen18X101629. doi: 10.3399/bjgpopen18X101629. eCollection 2019 Apr. — View Citation

Zanocchi M, Maero B, Nicola E, Martinelli E, Luppino A, Gonella M, Gariglio F, Fissore L, Bardelli B, Obialero R, Molaschi M. Chronic pain in a sample of nursing home residents: prevalence, characteristics, influence on quality of life (QoL). Arch Gerontol Geriatr. 2008 Jul-Aug;47(1):121-8. doi: 10.1016/j.archger.2007.07.003. Epub 2007 Nov 19. — View Citation

Zarowitz BJ, O'Shea TE. Demographic and clinical profile of nursing facility residents with gout. Consult Pharm. 2013 Jun;28(6):370-82. doi: 10.4140/TCP.n.2013.370. — View Citation

* 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