Caring for Aged Dementia Care Resident Study (CADRES) of person-centred care, dementia-care mapping, and usual care in dementia: a cluster-randomised trial

Abstract Background: In Denmark, exercise therapy in combination with work modifications is the first choice treatment for persons with shoulder complaints and high occupational shoulder exposures. To obtain this treatment they must visit several healthcare providers, which makes usual care fragmented and uncoordinated. Therefore, we developed a new intervention which unifies the expertise that is needed. The main hypotheses are that a group-based Shoulder-Café intervention will reduce (I) shoulder complaints and (II) occupational shoulder exposures more effectively than an individual-based Shoulder-Guidance intervention (active control – enhanced usual care). Methods: A cluster-randomised trial is conducted including 120 employees with high occupational shoulder exposures. Companies (clusters) are randomised to either Shoulder-Café or Shoulder-Guidance with a 1:1 allocation ratio. Participants are 18–65 years old and have an Oxford Shoulder Score (OSS) ≤ 40. Both interventions include a home-based shoulder exercise programme, assessment of shoulder exposures by technical measurements and self-report, and general information on how to reduce shoulder exposures. The Shoulder-Café course also includes three café meetings with physiotherapist-supervised exercises, clinical shoulder evaluation, education on shoulder anatomy, workplace-oriented counselling, and an opportunity for a workplace visit by a health and safety consultant. The primary outcomes are the OSS at 6 month follow-up (hypothesis I), and the mean number of minutes/day with the arm elevated > 60° shortly after end of intervention (hypothesis II). We will use mixed model analysis that allows for company clustering, and data will be analysed according to the intention-to-treat principle. Discussion: Persons with shoulder complaints and high occupational shoulder exposures are an obvious target group for secondary prevention efforts. We developed the Shoulder-Café to reduce shoulder complaints and shoulder exposures while unifying the expertise that is needed to evaluate and treat shoulder complaints. If the intervention is effective, it would warrant widespread implementation. Trial registration: The trial was registered at Clinicaltrials.gov on 18 May 2017 (ID: NCT03159910). Keywords: Exercise, Intervention, Mechanical exposure, Occupation, Randomised controlled trial, Shoulder, Training programme.

Download Full-text

Evaluating the effectiveness and cost effectiveness of Dementia Care Mapping (DCM) to enable person-centred care for people with dementia and their carers: A cluster randomised controlled trial in care homes (DCM EPIC trial)

http://isrctn.org/> ◽

10.1186/isrctn82288852 ◽

2014 ◽

Author(s):

Kayleigh Burton

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Dementia Care ◽

Cluster Randomised ◽

People With Dementia ◽

Randomised Controlled ◽

Care Mapping ◽

Dementia Care Mapping

Download Full-text

Behavioural graded activity results in better exercise adherence and more physical activity than usual care in people with osteoarthritis: a cluster-randomised trial

Journal of Physiotherapy ◽

10.1016/s1836-9553(10)70053-9 ◽

2010 ◽

Vol 56 (1) ◽

pp. 41-47 ◽

Cited By ~ 49

Author(s):

Martijn F. Pisters ◽

Cindy Veenhof ◽

Dinny H. de Bakker ◽

François G. Schellevis ◽

Joost Dekker

Keyword(s):

Physical Activity ◽

Usual Care ◽

Randomised Trial ◽

Exercise Adherence ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

Graded Activity

Download Full-text

Reducing shoulder complaints in employees with high occupational shoulder exposures: study protocol for a cluster-randomised controlled study (The Shoulder-Café Study)

10.21203/rs.2.328/v2 ◽

2019 ◽

Author(s):

Jeanette Trøstrup ◽

Lone Ramer Mikkelsen ◽

Poul Frost ◽

Annett Dalbøge ◽

Mette Terp Høybye ◽

...

Keyword(s):

Usual Care ◽

Mixed Model ◽

Randomised Trial ◽

General Information ◽

Self Report ◽

Controlled Study ◽

Cluster Randomised Trial ◽

Mixed Model Analysis ◽

Cluster Randomised ◽

First Choice

Abstract Background: In Denmark, exercise therapy in combination with work modifications is the first choice treatment for persons with shoulder complaints and high occupational shoulder exposures. To obtain this treatment they must visit several healthcare providers, which makes usual care fragmented and uncoordinated. Therefore, we developed a new intervention which unifies the expertise that is needed. The main hypotheses are that a group-based Shoulder-Café intervention will more effectively reduce (I) shoulder complaints and (II) occupational shoulder exposures than an individual-based Shoulder-Guidance intervention (active control – enhanced usual care). Methods: A cluster-randomised trial is conducted including 120 employees with high occupational shoulder exposures. Companies (clusters) are randomised to either Shoulder-Café or Shoulder-Guidance with a 1:1 allocation ratio. Participants are 18–65 years old and have an Oxford Shoulder Score (OSS) ≤ 40. Both interventions include a home-based shoulder exercise programme, assessment of shoulder exposures by technical measurements and self-report, and general information on how to reduce shoulder exposures. The Shoulder-Café course also includes three café meetings with physiotherapist-supervised exercises, clinical shoulder evaluation, education on shoulder anatomy, workplace-oriented counselling, and an opportunity for a workplace visit by a health and safety consultant. The primary outcomes are the OSS at 6 month follow-up (hypothesis I), and the mean number of minutes/day with the arm elevated > 60° shortly after end of intervention (hypothesis II). We will use mixed model analysis that allows for company clustering, and data will be analysed according to the intention-to-treat principle. Discussion: Persons with shoulder complaints and high occupational shoulder exposures are an obvious target group for secondary prevention efforts. We developed the Shoulder-Café to reduce shoulder complaints and shoulder exposures while unifying the expertise that is needed to evaluate and treat shoulder complaints. If the intervention is effective, it would warrant widespread implementation. Trial registration: The trial was registered at Clinicaltrials.gov on 18 May 2017 (ID: NCT03159910).

Download Full-text

Long-term clinical and cost-effectiveness of collaborative care (versus usual care) for people with mental–physical multimorbidity: cluster-randomised trial

The British Journal of Psychiatry ◽

10.1192/bjp.2018.70 ◽

2018 ◽

Vol 213 (2) ◽

pp. 456-463 ◽

Cited By ~ 19

Author(s):

Elizabeth M. Camacho ◽

Linda M. Davies ◽

Mark Hann ◽

Nicola Small ◽

Peter Bower ◽

...

Keyword(s):

Cost Effectiveness ◽

Usual Care ◽

Collaborative Care ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Depression Symptoms ◽

Long Term Conditions ◽

Cluster Randomised ◽

Life Years

BackgroundCollaborative care can support the treatment of depression in people with long-term conditions, but long-term benefits and costs are unknown.AimsTo explore the long-term (24-month) effectiveness and cost-effectiveness of collaborative care in people with mental-physical multimorbidity.MethodA cluster randomised trial compared collaborative care (integrated physical and mental healthcare) with usual care for depression alongside diabetes and/or coronary heart disease. Depression symptoms were measured by the symptom checklist-depression scale (SCL-D13). The economic evaluation was from the perspective of the English National Health Service.Results191 participants were allocated to collaborative care and 196 to usual care. At 24 months, the mean SCL-D13 score was 0.27 (95% CI, −0.48 to −0.06) lower in the collaborative care group alongside a gain of 0.14 (95% CI, 0.06-0.21) quality-adjusted life-years (QALYs). The cost per QALY gained was £13 069.ConclusionsIn the long term, collaborative care reduces depression and is potentially cost-effective at internationally accepted willingness-to-pay thresholds.Declaration of interestNone.

Download Full-text

Effectiveness and cost-effectiveness of duloxetine added to usual care for patients with chronic pain due to hip or knee osteoarthritis: protocol of a pragmatic open-label cluster randomised trial (the DUO trial)

BMJ Open ◽

10.1136/bmjopen-2017-018661 ◽

2017 ◽

Vol 7 (9) ◽

pp. e018661 ◽

Cited By ~ 1

Author(s):

Jacoline J van den Driest ◽

Dieuwke Schiphof ◽

Pim A J Luijsterburg ◽

Aafke R Koffeman ◽

Marc A Koopmanschap ◽

...

Keyword(s):

Chronic Pain ◽

Usual Care ◽

Open Cluster ◽

Randomised Trial ◽

Response To Treatment ◽

Cluster Randomised Trial ◽

Womac Pain ◽

Painful Condition ◽

Cluster Randomised ◽

Pain Subscale

IntroductionOsteoarthritis (OA) is a highly prevalent painful condition of the musculoskeletal system. The effectiveness of current analgesic options has proven to be limited and improved analgesic treatment is needed. Several randomised placebo-controlled trials have now demonstrated the efficacy of duloxetine, an antidepressant with a centrally acting effect, in the treatment of OA pain. The aim of the current study is to investigate if duloxetine is effective and cost-effective as a third-choice analgesic added to usual care for treating chronic pain compared with usual care alone in general practice.Methods and analysisA pragmatic open, cluster randomised trial is conducted. Patients with pain due to hip or knee OA on most days of the past 3 months with insufficient benefit of non-steroidal anti-inflammatory drugs or contraindications or intolerable side effects are included. General practices are randomised to either (1) duloxetine and usual care or (2) usual care only. Primary outcome is pain at 3 months measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. Secondary outcomes at 3 months and 1 year are pain (WOMAC, at 1 year), function (WOMAC), adverse reactions, quality of life and modification of the response to treatment by the presence of centrally sensitised pain (modified PainDETECT). At 1 year, medical and productivity costs will be assessed. Analyses will be performed following the intention-to-treat principle taking the cluster design into account.Ethics and disseminationThe study is approved by the local Medical Ethics Committee (2015–293). Results will be published in a scientific peer-reviewed journal and will be communicated at conferences.Trial registration numberDutch Trial Registry(ntr4798); Pre-results.

Download Full-text