Intervention to reduce sedentary behaviour and improve outcomes after stroke (Get Set Go): a study protocol for the process evaluation of a pilot cluster randomised controlled trial (RECREATE)

被引:0
|
作者
Johansson, Jessica Faye [1 ,2 ]
Shannon, Rosie [2 ]
Mossabir, Rahena [2 ]
Airlie, Jennifer [2 ]
Ozer, Seline [2 ]
Moreau, Lauren A. [3 ]
Farrin, Amanda [3 ]
Mead, Gillian [4 ]
English, Coralie [5 ,6 ]
Fitzsimons, Claire F. [7 ]
Clarke, David J. [1 ,2 ]
Forster, Anne [1 ,2 ]
RECREATE Programme Management Grp
机构
[1] Univ Leeds, Leeds Inst Hlth Sci, Acad Unit Ageing & Stroke Res, Leeds, England
[2] Bradford Teaching Hosp NHS Fdn Trust, Bradford Inst Hlth Res, Acad Unit Ageing & Stroke Res, Bradford, England
[3] Univ Leeds, Leeds Inst Clin Trials Res, Clin Trials Res Unit CTRU, Leeds, England
[4] Univ Edinburgh, Ctr Clin Brain Sci, Edinburgh, Scotland
[5] Univ Newcastle, Sch Hlth Sci, Newcastle, NSW, Australia
[6] Univ Newcastle, Hunter Med Res Inst, Heart & Stroke Res Program, Newcastle, NSW, Australia
[7] Univ Edinburgh, Inst Sport Phys Educ & Hlth Sci, Phys Act Hlth & Res Ctr, Edinburgh, Scotland
来源
BMJ OPEN | 2023年 / 13卷 / 09期
关键词
Stroke; PUBLIC HEALTH; QUALITATIVE RESEARCH; Clinical trials; PHYSICAL-ACTIVITY; PEOPLE; PREVALENCE; ADULTS; TIME;
D O I
10.1136/bmjopen-2023-075363
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
IntroductionStroke survivors spend long periods of time engaging in sedentary behaviour (SB) even when their functional recovery is good. In the RECREATE programme, an intervention aimed at reducing SB ('Get Set Go') will be implemented and evaluated in a pragmatic external pilot cluster randomised controlled trial with embedded process and economic evaluations. We report the protocol for the process evaluation which will address the following objectives: (1) describe and clarify causal assumptions about the intervention, and its mechanisms of impact; (2) assess implementation fidelity; (3) explore views, perceptions and acceptability of the intervention to staff, stroke survivors and their carers; (4) establish the contextual factors that influence implementation, intervention mechanisms and outcomes.Methods and analysisThis pilot trial will be conducted in 15 UK-based National Health Service stroke services. This process evaluation study, underpinned by the Medical Research Council guidance, will be undertaken in six of the randomised services (four intervention, two control). Data collection includes the following: observations of staff training sessions, non-participant observations in inpatient and community settings, semi-structured interviews with staff, patients and carers, and documentary analysis of key intervention components. Additional quantitative implementation data will be collected in all sites. Training observations and documentary analysis data will be summarised, with other observational and interview data analysed using thematic analysis. Relevant theories will be used to interpret the findings, including the theoretical domains framework, normalisation process theory and the theoretical framework of acceptability. Anticipated outputs include the following: recommendations for intervention refinements (both content and implementation); a revised implementation plan and a refined logic model.Ethics and disseminationThe study was approved by Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (REC reference: 19/YH/0403). Findings will be disseminated via peer review publications, and national and international conference presentations.Trial registration numberISRCTN82280581.
引用
收藏
页数:12
相关论文
共 50 条
  • [41] Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial
    Sheard, Laura
    O'Hara, Jane
    Armitage, Gerry
    Wright, John
    Cocks, Kim
    McEachan, Rosemary
    Watt, Ian
    Lawton, Rebecca
    TRIALS, 2014, 15
  • [42] A mobile technology intervention to reduce sedentary behaviour in 2-to 4-year-old children (Mini Movers): study protocol for a randomised controlled trial
    Downing, Katherine L.
    Salmon, Jo
    Hinkley, Trina
    Hnatiuk, Jill A.
    Hesketh, Kylie D.
    TRIALS, 2017, 18
  • [43] A mobile technology intervention to reduce sedentary behaviour in 2- to 4-year-old children (Mini Movers): study protocol for a randomised controlled trial
    Katherine L. Downing
    Jo Salmon
    Trina Hinkley
    Jill A. Hnatiuk
    Kylie D. Hesketh
    Trials, 18
  • [44] Multiprofessional intervention to improve adherence to medication in stroke patients: a study protocol for a randomised controlled trial (ADMED AVC study)
    Khettar, Sophie
    Courtois, Sophie Jacquin
    Luaute, Jacques
    Decullier, Evelyne
    Bin, Sylvie
    Dupuis, Marine
    Derex, Laurent
    Mechtouff, Laura
    Nighoghossian, Norbert
    Dussart, Claude
    Rode, Gilles
    Janoly-Dumenil, Audrey
    EUROPEAN JOURNAL OF HOSPITAL PHARMACY, 2022, 29 (03) : 169 - 175
  • [45] Improving Primary Care After Stroke (IPCAS) randomised controlled trial: protocol for a multidimensional process evaluation
    Aquino, Maria Raisa Jessica
    Mullis, Ricky
    Kreit, Elizabeth
    Johnson, Vicki
    Grant, Julie
    Lim, Lisa
    Sutton, Stephen
    Mant, Jonathan
    BMJ OPEN, 2020, 10 (07): : e036879
  • [46] Process evaluation protocol for a cluster randomised trial of a complex, nurse-led intervention to improve hypertension management in India
    Venkateshmurthy, Nikhil Srinivasapura
    Mc Namara, Kevin
    Koorts, Harriet
    Mohan, Sailesh
    Ajay, Vamadevan S.
    Jindal, Devraj
    Malipeddi, Bhaskara Rao
    Roy, Ambuj
    Tandon, Nikhil
    Prabhakaran, Dorairaj
    Worsley, Tony
    Maddison, Ralph
    O'Reilly, Sharleen
    BMJ OPEN, 2019, 9 (05):
  • [47] Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in elderly care units: study protocol
    Drahota, Amy
    Gal, Diane
    Windsor, Julie
    Dixon, Simon
    Udell, Julie
    Ward, Derek
    Soilemezi, Dia
    Dean, Taraneh
    Severs, Martin
    INJURY PREVENTION, 2011, 17 (06) : 1 - 10
  • [48] A Pilot Randomised Clinical Trial of a Novel Approach to Reduce Sedentary Behaviour in Care Home Residents: Feasibility and Preliminary Effects of the GET READY Study
    Gine-Garriga, Maria
    Dall, Philippa M.
    Sandlund, Marlene
    Jerez-Roig, Javier
    Chastin, Sebastien F. M.
    Skelton, Dawn A.
    INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH, 2020, 17 (08)
  • [49] A cluster randomised controlled trial of a comprehensive accreditation intervention to reduce alcohol consumption at community sports clubs: study protocol
    Kingsland, Melanie
    Wolfenden, Luke
    Rowland, Bosco C.
    Tindall, Jennifer
    Gillham, Karen E.
    McElduff, Patrick
    Rogerson, John C.
    Wiggers, John H.
    BMJ OPEN, 2011, 1 (02):
  • [50] PRegnancy Outcomes after a Maternity Intervention for Stressful EmotionS (PROMISES): study protocol for a randomised controlled trial
    Judith L Meijer
    Claudi LH Bockting
    Chantal Beijers
    Tjitte Verbeek
    A Dennis Stant
    Johan Ormel
    Ronald P Stolk
    Peter de Jonge
    Mariëlle G van Pampus
    Huibert Burger
    Trials, 12