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Improved participation of older people with joint contractures living in nursing homes: feasibility of study procedures in a cluster-randomised pilot trial.

ABSTRACT: BACKGROUND:Acquired 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. METHODS:Nursing 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. RESULTS:Seven 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. CONCLUSION:Our 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 REGISTRATION:German clinical trials register, ID: DRKS00010037 . Registered on 12 February 2016.

SUBMITTER: Saal S

PROVIDER: S-EPMC6617884 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Improved participation of older people with joint contractures living in nursing homes: feasibility of study procedures in a cluster-randomised pilot trial.

Saal Susanne S Klingshirn Hanna H Beutner Katrin K Strobl Ralf R Grill Eva E Müller Martin M Meyer Gabriele G

Trials 20190709 1

<h4>Background</h4>Acquired 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 ...[more]

PMID: 31288846

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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:BackgroundNursing 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/designThis 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.DiscussionWe 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 registrationDRKS, DRKS00015185 . Registered on 1 August 2018. Universal Trial Number U1111-1218-1555. Registered on 26 July 2018.

Project description:BackgroundOlder adults living in nursing homes spend the majority of their time inactive. The associated levels of chronic disease place an increasing burden on healthcare systems. Physical activity (PA) interventions delivered through exercise classes may be resource-intensive and require specialist staff. The aim of this study is to explore the feasibility and acceptability of a PA programme embedded into the daily lives of older adults living in nursing homes and to examine the preliminary effects of this on physical mobility and quality of life.MethodsA randomised controlled pilot feasibility study, including embedded qualitative and economic components will be carried out. Two randomly selected nursing homes will take part in the study; participants (n = 20) in one nursing home will receive a three-month PA intervention and participants (n = 20) in the other will be a usual care control. Nursing home staff will be provided with training and support to monitor participants PA programmes. Feasibility data will be collected on recruitment, randomisation, assessment and intervention procedures. Criteria for progression of the pilot feasibility study to a definitive trial will be specified. The Timed Up and Go test, Nottingham Health Profile, 10-Metre Walk test, the Investigating Choice Experiments for the Preferences of Older People Capability index and the Bangor Goal Setting Interview will be assessed at baseline, three-month and 12-month follow-up. Between-group and within-individual effects will be estimated using appropriate linear mixed models. Semi-structured interviews will be conducted with staff and participants of the intervention group within one month after the intervention to explore the feasibility and acceptability of the programme. A subset of control participants will be interviewed to describe usual care. Economic data will be collected to examine costs of the intervention in comparison with costs in the control group.DiscussionThe findings will facilitate refinement of the PA programme and development of a clear protocol for subsequent evaluation of the PA intervention in a definitive randomised controlled trial.Trial registrationClinicalTrials.gov, NCT03484715 . Registered on 30 March 2018.

Project description:BackgroundThis survey aims to evaluate the prevalence and severity of tooth loss in the Italian elderly population living in nursing homes and to associate the oral data with demographic, socioeconomic factors, the Mini-Mental State Examination (MMSE), the Body Mass Index (BMI) and the Mini Nutritional Assessment (MNA) scores.MethodsA cluster sample method was performed using each nursing home as a cluster. Twenty-three nursing homes located in the five areas of the Italy (North-West, North-East, Centre, South and Islands) were selected. An informed consent to participate was distributed by the personnel of the selected nursing homes and signed directly by subjects/caregivers; 2114 forms were distributed, 1998 forms signed and finally 1976 subjects were examined. Chewing ability was scored as good (≥10 functional units (FUs)), sufficient (7-10 FUs), and insufficient (< 7 FUs). The presence of prosthetic dental restorations was summarized as: absent of prosthesis, fixed prosthesis, removable prosthesis, combined prosthesis. Age, gender, socioeconomic status, MMSE, BMI and MNA were obtained from medical charts.ResultsAlmost three quarters of the subjects were ≥ 80 years old (74.37%) and women (74.04%). The prevalence of edentulism was 42.10% with a large variation among the five areas of Italy (from 34.43% in Centre to 53.46% in North-West). Insufficient presence of FUs was preeminent in each age group (prevalence 42.10%) and statistically associated to age and to female gender (p < 0.01). Overweight/obese (7.47%) subjects showed the highest FUs. Area of living, MMSE (both < 0.01), BMI (p = 0.01) were statistically significant associated to the type of prosthetic dental restorations in the oldest group. Subjects with no mental impairment showed the highest percentage of prosthetic dental restorations (32.36%).ConclusionsMore than half of the sample has an insufficient number of functional units for chewing and this is more pronounced in females. The presence and the type of prosthetic dental restorations are linked to cognitive impairment: the higher is the mental impairment the higher is the number of subjects with absence of prosthetic restorations. The findings of this national survey highlight the need for public health policy, aiming to increase awareness regarding oral health though health education.

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Improved participation of older people with joint contractures living in nursing homes: feasibility of study procedures in a cluster-randomised pilot trial.

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Improved participation of older people with joint contractures living in nursing homes: feasibility of study procedures in a cluster-randomised pilot trial.

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