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Effectiveness of a complex intervention to improve participation and activities in nursing home residents with joint contractures (JointConEval): study protocol of a multicentre cluster-randomised controlled trial [DRKS-ID:DRKS00015185].

ABSTRACT: BACKGROUND:Nursing home residents are frequently affected by joint contractures, which impacts their participation and daily activities. A complex intervention, the Participation Enabling Care in Nursing (PECAN), was previously developed and pilot tested to address their needs. Its effectiveness and safety will be evaluated in the present study. METHODS/DESIGN:This multicentre cluster-randomised controlled trial will be conducted in 32 nursing homes spread over two regions of Germany. A total of 578 residents over 65?years old with joint contractures will be included. To compare the effect of the PECAN intervention with optimised standard care (usual care and an information session), randomisation will take place at a cluster level. The individually tailored intervention was designed using the biopsychosocial model in the International Classification of Functioning, Disability and Health (ICF) to reduce activity limitations and participation restrictions resulting from existing joint contractures by addressing barriers and by strengthening supportive factors on an individual level and an organisational level. The implementation strategy comprises a facilitators' workshop, a peer mentoring approach including a peer mentor visit and telephone peer counselling, an in-house information event, an information session for the nursing team and a training session on collegial consultation for the facilitators. The in-house information event will also take place in the nursing homes of the control group. The primary outcome is the residents' participation and activities after 12?months of follow-up as assessed using the PaArticular Scales. The secondary outcome is the residents' quality of life. A cost-effectiveness analysis (costs per additional resident who experienced a decrease of ten points in the participation or activities subscale of the PaArticular Scales) and a cost-utility analysis (costs per additional quality adjusted life year) will be conducted. We will investigate barriers and facilitators in a comprehensive process evaluation. DISCUSSION:We expect a clinically relevant improvement of participation and activities in residents with joint contractures. Our findings will provide important insights regarding participation in the situation of the affected individuals. TRIAL REGISTRATION:DRKS, DRKS00015185 . Registered on 1 August 2018. Universal Trial Number U1111-1218-1555. Registered on 26 July 2018.

SUBMITTER: Nguyen N

PROVIDER: S-EPMC6542100 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Effectiveness of a complex intervention to improve participation and activities in nursing home residents with joint contractures (JointConEval): study protocol of a multicentre cluster-randomised controlled trial [DRKS-ID:DRKS00015185].

Nguyen Natalie N Thalhammer Regina R Beutner Katrin K Saal Susanne S Servaty Ricarda R Klingshirn Hanna H Icks Andrea A Freyberg Kristina K Vomhof Markus M Mansmann Ulrich U Le Lien L Müller Martin M Meyer Gabriele G

Trials 20190529 1

<h4>Background</h4>Nursing home residents are frequently affected by joint contractures, which impacts their participation and daily activities. A complex intervention, the Participation Enabling Care in Nursing (PECAN), was previously developed and pilot tested to address their needs. Its effectiveness and safety will be evaluated in the present study.<h4>Methods/design</h4>This multicentre cluster-randomised controlled trial will be conducted in 32 nursing homes spread over two regions of Germ ...[more]

PMID: 31142350

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Project description:BackgroundAcquired joint contractures have a significant impact on functioning and quality of life in nursing home residents. There is very limited evidence on measures for prevention and treatment of disability due to joint contractures. We have developed the PECAN intervention (Participation Enabling CAre in Nursing) to improve social participation in nursing home residents. A cluster-randomised pilot trial was conducted to assess the feasibility of study procedures in preparation for a main trial according to the UK Medical Research Council (MRC) framework.MethodsNursing homes in two regions of Germany were randomly allocated either to the intervention or optimised standard care (control group). All residents with joint contractures aged > 65 years were eligible for the study. The residents' data were collected through structured face-to-face interviews by blinded assessors at baseline, after 3 and 6 months. The primary outcome was social participation, measured by a subscale of the PaArticular Scales. Secondary outcomes included activities and instrumental activities of daily living, health-related quality of life, falls and fall-related consequences. Data on the trial feasibility were collected via documentation forms.ResultsSeven out of 12 nursing homes agreed to participate and remained in the trial. Of 265 residents who fulfilled the inclusion criteria, 129 were randomised either to the intervention (n = 64) or control group (n = 65) and analysed. A total of 109 (85%) completed the trial after 6 months. The mean age was 85.7 years (SD 7.0), 80% were women. The severity of the residents' disability differed across the clusters. The completion rate was high (> 95%), apart from the Instrumental Activities of Daily Living Scale. Some items of the PaArticular Scales were not easily understood by residents. The frequency of falls did not differ between study groups.ConclusionOur data confirmed the feasibility of the overall study design. We also revealed the need to improve the procedures for the recruitment of residents and for data collection before implementation into a main trial. The next step will be an adequately powered main trial to assess the effectiveness and cost-effectiveness of the intervention.Trial registrationGerman clinical trials register, ID: DRKS00010037 . Registered on 12 February 2016.

Project description:BackgroundJoint contractures and degenerative osteoarthritis are the most common joint diseases in the elderly population, can lead to limited mobility in elderly individuals, can exacerbate symptoms such as pain, stiffness, and disability, and can interfere with social participation and quality of life, thus affecting mental health. However, relevant studies on this topic are very limited. This study describes the associations of joint contracture categories and sites in elderly residents in long-term care facilities with their quality of life, activities, and participation.MethodsElderly individuals with joint contractures who were residents in long-term care facilities were recruited. The World Health Organization (WHO) Quality of Life and the WHO Disability Assessment Schedule 2.0 were used to survey the participants. Correlations, multiple linear regressions, and multiple analyses of variance, with joint contractures as the response variable, were used in the statistical analysis.ResultsThe final statistical analysis included 232 participants. The explanatory power of contracture sites on activities and participation had a moderate strength of association (η2 = .113). Compared with elderly residents with joint contractures and osteoarthritis isolated to the upper limbs, those with joint contractures and osteoarthritis in both the upper and lower limbs had significantly worse activity and participation limitations. No significant differences in activity and participation were found between elderly residents with joint contractures affecting only the upper limbs and those with joint contractures affecting only the lower limbs (F1,226 = 2.604 and F1,226 = 0.674, nonsignificant). Osteoarthritis had the greatest impact on activity limitations and participation restrictions among elderly residents with joint contractures affecting both the upper and lower limbs (F1,226 = 6.251, p = .014).ConclusionsElderly residents in long-term care facilities belonging to minority groups, with a history of stroke, and with osteoarthritis are at a high risk of developing activity limitations and participation restrictions. Moreover, compared with other contraction sites, regardless of osteoarthritis, joint contractures affecting both the upper and lower limbs were associated with the greatest activity limitations and participation restrictions.Trial registrationThis study has been registered in the Chinese Clinical Trial Registry, registration number and date: ChiCTR2000039889 (13/11/2020).

Project description:BACKGROUND:Joint contractures in frail older people are associated with serious restrictions in participation. We developed the Participation Enabling CAre in Nursing (PECAN) intervention, a complex intervention to enable nurses to promote participation in nursing home residents with joint contractures. The aim of this study was to examine the feasibility of the implementation strategy and to identify enablers and barriers for a successful implementation. METHODS:The implementation of PECAN was investigated in a 6-month pilot cluster-randomised controlled trial (c-RCT). As a key component of the implementation strategy, nominated nurses were trained as facilitators in a one-day workshop and supported by peer-mentoring (visit, telephone counselling). A mixed-methods approach was conducted in conjunction with the pilot trial and guided by a framework for process evaluations of c-RCTs. Data were collected using standardised questionnaires (nursing staff), documentation forms, problem-centred qualitative interviews (facilitators, therapists, social workers, relatives, peer-mentors), and a group discussion (facilitators). A set of predefined criteria on the nursing home level was examined. Quantitative data were analysed using descriptive statistics. Qualitative data were analysed using directed content analysis. RESULTS:Seven nursing homes (n =?4 intervention groups, n =?3 control groups) in two regions of Germany took part in the study. Facilitators responded well to the qualification measures (workshop participation: 14/14; workshop rating: "good"; peer-mentor visit participation: 10/14). The usage of peer-mentoring via telephone varied (one to seven contacts per nursing home). Our implementation strategy was not successful in connection with supplying the intervention to all the nurses. The clear commitment of the entire nursing home and the respect for the expertise of different healthcare professionals were emphasised as enablers, whereas a lack of impact on organisational conditions and routines and a lack of time and staff competence were mentioned as barriers. CONCLUSION:The PECAN intervention was delivered as planned to the facilitators but was unable to produce comprehensive changes in the nursing homes and subsequently for the residents. Strategies to systematically include the management and the nursing team from the beginning are needed to support the facilitators during implementation in the main trial. TRIAL REGISTRATION:German clinical trials register, DRKS00010037 . Registered 12 February 2016.

Project description:OBJECTIVE:This study aimed to explore the relationship between dependence in Activities of Daily Living and muscle strength, muscle morphology and physical function in older nursing home residents, taking possible confounders into consideration. METHODS:A total of 30 nursing home residents (age, 85.6±7.1 years) were included in this observational cross-sectional study. Performance of basic Activities of Daily Living (ADL) was assessed with the Resident Assessment Instrument and categorized as either independent or dependent. Isometric grip, quadriceps and elbow-flexor strength were determined by hand-dynamometry, muscle thickness and echo intensity by B-mode ultrasonography, a sit-to-stand task by using a stop watch and physical activity by the German-Physical-Activity Questionnaire. Degree of frailty was evaluated according to Fried's frailty criteria, whereas cognition, depression, incontinence, pain and falls were part of the Resident Assessment Instrument. RESULTS:Dependence in Activities of Daily Living was negatively correlated with physical activity (rs = -0.44, p = .015), handgrip (rs = -0.38, p = .038), elbow-flexor (rs = -0.42, p = .032) and quadriceps strength (rs = -0.67, p < .001), analysed by Spearman's correlation. Chronic diseases (rs = -0.41, p = .027) and incontinence (rs = -0.39, p = .037) were positively correlated with ADL while the other variables were not related. Only quadriceps strength remained significant with logistic regression (Wald(1) = 4.7, p = .03), when chronic diseases, quadriceps and handgrip strength were considered (R2 .79). 11 kg was the best fitting value in this sample to predict performance in Activities of Daily Living, evaluated with Receiver-Operating Characteristic analysis, with a sensitivity of 100% and a specificity of 79%. CONCLUSION AND IMPLICATION:Quadriceps strength had a positive independent relationship with performance in ADL in the nursing home residents studied. Although a large prospective study is needed to verify the results, maintaining quadriceps strength above 11 kg may be helpful in retaining independence in this cohort.

Dataset Information

Effectiveness of a complex intervention to improve participation and activities in nursing home residents with joint contractures (JointConEval): study protocol of a multicentre cluster-randomised controlled trial [DRKS-ID:DRKS00015185].

Publications

Effectiveness of a complex intervention to improve participation and activities in nursing home residents with joint contractures (JointConEval): study protocol of a multicentre cluster-randomised controlled trial [DRKS-ID:DRKS00015185].

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