Effect of adjusting the challenge–skill balance for occupational therapy: study protocol for a randomised controlled trial

IntroductionOccupational therapy (OT) is defined as the promotion of client health and well-being through a client-centred practice. However, there is a tendency to rely on the therapist’s experiences and values, and there is a difference between the client’s and therapist’s perceptions regarding the current activity that the client is engaged in. In previous studies that have applied ‘flow’, activities supported by OT in elderly people were analysed, indicating a difference in recognition. Therefore, we thought that more effective OT could be implemented by adjusting the challenge–skill (ACS) balance, and we invented a novel process termed as ACS balance for OT. The purpose of this study is to verify the effect of ACS-OT on clients in the recovery rehabilitation unit and to prepare a protocol for randomised controlled trial (RCT) implementation.Method and analysisThis single-blind RCT will recruit 80 clients aged 50–99 years admitted to the recovery rehabilitation unit who meet eligibility criteria. Clients will be randomly allocated to receive ACS-OT or standard OT. Both interventions will be performed during the clients’ residence at the unit. The primary outcome measure will be subjective quality of life and will be measured at entry into (pre) and at discharge from (post) the unit and at 3 months afterwards (follow-up). Outcomes will be analysed using a linear mixed model fitted with a maximum likelihood estimation.Ethics and disseminationThis protocol has been approved by the ethics review committee of the Tokyo Metropolitan University (No.17020). Results of this trial will be submitted for publication in a peer-reviewed journal.Trial registration numberUMIN-CTR number, UMIN000029505; Pre-results.

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Combined effect of pill refilling and self-medication reminder system on patients’ adherence to tuberculosis treatment during continuation phase in Northwest Ethiopia: a study protocol for randomised controlled trial

BMJ Health & Care Informatics ◽

10.1136/bmjhci-2019-100050 ◽

2019 ◽

Vol 26 (1) ◽

pp. e100050

Author(s):

Kassahun Dessie Gashu ◽

Kassahun Alemu Gelaye ◽

Richard Lester ◽

Binyam Tilahun

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Mixed Model ◽

Linear Mixed Model ◽

Controlled Trial ◽

Treatment Phase ◽

Tb Treatment ◽

Generalised Linear Mixed Model ◽

Continuation Treatment ◽

Randomised Controlled

IntroductionPatients’ failure to adhere on tuberculosis (TB) treatment leads to drug resistance, relapse and death. Non-adherence to TB treatment is higher during continuation treatment phase. The study aimed to evaluate effectiveness of combined pill refilling and medication reminders on adherence to TB treatment.Methods and analysisA two-arm randomised controlled trial on adult patients with TB was used during continuation treatment phase. In the first arm, in addition to usual care, participants will receive cellphone-based daily medication and weekly pill refilling reminders. In the control arm, participants will receive only usual care. The study will use a covariate adaptive randomisation technique to balance covariates during allocation. The primary outcome is patients’ adherence to TB treatment and secondary outcomes are attendance to clinic and treatment outcomes. We apply intention to treat with generalised linear mixed model.Ethics and disseminationEthical approval was obtained from Institutional Review Board of University of Gondar. Written informed consent was applied during enrolment. We will publish findings in peer-reviewed, scientific journals and conferences.Trial registration numberPACTR201901552202539.

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A pragmatic, unblinded randomised controlled trial comparing an occupational therapy-led lifestyle approach and routine GP care for panic disorder treatment in primary care

Yearbook of Psychiatry and Applied Mental Health ◽

10.1016/s0084-3970(08)70815-6 ◽

2008 ◽

Vol 2008 ◽

pp. 237-238

Author(s):

J.C. Ballenger

Keyword(s):

Primary Care ◽

Randomised Controlled Trial ◽

Panic Disorder ◽

Occupational Therapy ◽

Controlled Trial ◽

Disorder Treatment ◽

Randomised Controlled ◽

Gp Care

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Faculty Opinions recommendation of Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.1160807.628059 ◽

2009 ◽

Author(s):

Babak Sarani

Keyword(s):

Randomised Controlled Trial ◽

Occupational Therapy ◽

Critically Ill ◽

Critically Ill Patients ◽

Controlled Trial ◽

Mechanically Ventilated ◽

Randomised Controlled

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Study design, rationale and methods of the Revitalising Informal Settlements and their Environments (RISE) study: a cluster randomised controlled trial to evaluate environmental and human health impacts of a water-sensitive intervention in informal settlements in Indonesia and Fiji

BMJ Open ◽

10.1136/bmjopen-2020-042850 ◽

2021 ◽

Vol 11 (1) ◽

pp. e042850

Author(s):

Karin Leder ◽

John J Openshaw ◽

Pascale Allotey ◽

Ansariadi Ansariadi ◽

S Fiona Barker ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Human Health ◽

Controlled Trial ◽

Informal Settlements ◽

Cluster Randomised Controlled Trial ◽

Well Being ◽

Cluster Randomised ◽

Abundance And Diversity ◽

Randomised Controlled ◽

Health And Well Being

IntroductionIncreasing urban populations have led to the growth of informal settlements, with contaminated environments linked to poor human health through a range of interlinked pathways. Here, we describe the design and methods for the Revitalising Informal Settlements and their Environments (RISE) study, a transdisciplinary randomised trial evaluating impacts of an intervention to upgrade urban informal settlements in two Asia-Pacific countries.Methods and analysisRISE is a cluster randomised controlled trial among 12 settlements in Makassar, Indonesia, and 12 in Suva, Fiji. Six settlements in each country have been randomised to receive the intervention at the outset; the remainder will serve as controls and be offered intervention delivery after trial completion. The intervention involves a water-sensitive approach, delivering site-specific, modular, decentralised infrastructure primarily aimed at improving health by decreasing exposure to environmental faecal contamination. Consenting households within each informal settlement site have been enrolled, with longitudinal assessment to involve health and well-being surveys, and human and environmental sampling. Primary outcomes will be evaluated in children under 5 years of age and include prevalence and diversity of gastrointestinal pathogens, abundance and diversity of antimicrobial resistance (AMR) genes in gastrointestinal microorganisms and markers of gastrointestinal inflammation. Diverse secondary outcomes include changes in microbial contamination; abundance and diversity of pathogens and AMR genes in environmental samples; impacts on ecological biodiversity and microclimates; mosquito vector abundance; anthropometric assessments, nutrition markers and systemic inflammation in children; caregiver-reported and self-reported health symptoms and healthcare utilisation; and measures of individual and community psychological, emotional and economic well-being. The study aims to provide proof-of-concept evidence to inform policies on upgrading of informal settlements to improve environments and human health and well-being.EthicsStudy protocols have been approved by ethics boards at Monash University, Fiji National University and Hasanuddin University.Trial registration numberACTRN12618000633280; Pre-results.

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Comment on—Effects of family participatory dignity therapy on the psychological well-being and family function of patients with haematological malignancies and their family caregivers: a randomised controlled trial

International Journal of Nursing Studies ◽

10.1016/j.ijnurstu.2021.103945 ◽

2021 ◽

pp. 103945

Author(s):

Professor Richard Gray

Keyword(s):

Randomised Controlled Trial ◽

Family Caregivers ◽

Controlled Trial ◽

Well Being ◽

Haematological Malignancies ◽

Psychological Well Being ◽

Family Function ◽

Dignity Therapy ◽

Randomised Controlled

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A randomised controlled trial to test a non-metallic deodorant used during a course of radiotherapy

Journal of Radiotherapy in Practice ◽

10.1017/s1460396999000321 ◽

2000 ◽

Vol 1 (4) ◽

pp. 205-212 ◽

Cited By ~ 19

Author(s):

A. Gee ◽

D. Moffitt ◽

M. Churn ◽

R.D. Errington

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Well Being ◽

Psychological Benefits ◽

Weekly Basis ◽

Skin Reactions ◽

Treated Area ◽

The Past ◽

Randomised Controlled ◽

Larger Sample

Background: Radiotherapy skin reactions have been well documented in the past. Until recently, washing of the treated area and the use of perfumed products that contain metals has not been advocated during treatment. The aims of this study were to assess the skin reactions of patients using a non-metallic deodorant and to see whether there were any psychological benefits from being able to use the deodorant.Method: 41 women attending for radiotherapy to either the breast or breast and axilla were recruited into the trial. They were randomised into one of two groups. Complete data was obtained for 36 patients. 20 patients used the deodorant and 16 did not. Any skin reactions noted were recorded on a weekly basis. Patients were also asked to complete a questionnaire relating to feelings and activities and to comment on the deodorant if they had used it.Results: Skin reactions did seem to be slightly worse in the patients using deodorant, and it was only in this group of patients that axillary reactions were noted. However, neither of these results were statistically significant. The use of the deodorant did not have any impact on the psychological well being of the patients, but patients using it had found it pleasant to use and the majority said that they would use it again.Conclusion: Further study is indicated to look at skin reactions using the deodorant with a larger sample of patients.

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