Multicentred randomised controlled trial of an augmented exercise referral scheme using web-based behavioural support in individuals with metabolic, musculoskeletal and mental health conditions

protocol for the e-coachER trial

Trial Steering Committee

Research output: Contribution to journalArticle

Abstract

INTRODUCTION: Physical activity is recommended for improving health among people with common chronic conditions such as obesity, diabetes, hypertension, osteoarthritis and low mood. One approach to promote physical activity is via primary care exercise referral schemes (ERS). However, there is limited support for the effectiveness of ERS for increasing long-term physical activity and additional interventions are needed to help patients overcome barriers to ERS uptake and adherence.This study aims to determine whether augmenting usual ERS with web-based behavioural support, based on the LifeGuide platform, will increase long-term physical activity for patients with chronic physical and mental health conditions, and is cost-effective.

METHODS AND ANALYSIS: A multicentre parallel two-group randomised controlled trial with 1:1 individual allocation to usual ERS alone (control) or usual ERS plus web-based behavioural support (intervention) with parallel economic and mixed methods process evaluations. Participants are low active adults with obesity, diabetes, hypertension, osteoarthritis or a history of depression, referred to an ERS from primary care in the UK.The primary outcome measure is the number of minutes of moderate-to-vigorous physical activity (MVPA) in ≥10 min bouts measured by accelerometer over 1 week at 12 months.We plan to recruit 413 participants, with 88% power at a two-sided alpha of 5%, assuming 20% attrition, to demonstrate a between-group difference of 36-39 min of MVPA per week at 12 months. An improvement of this magnitude represents an important change in physical activity, particularly for inactive participants with chronic conditions.

ETHICS AND DISSEMINATION: Approved by North West Preston NHS Research Ethics Committee (15/NW/0347). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals.Results will be disseminated to ERS services, primary healthcare providers and trial participants.

TRIAL REGISTRATION NUMBER: ISRCTN15644451; Pre-results.

Original languageEnglish
Article numbere022382
JournalBMJ Open
Volume8
Issue number9
Early online date21 Sep 2018
DOIs
Publication statusPublished - 21 Sep 2018

Keywords

  • Activities of Daily Living/psychology
  • Chronic Disease/psychology
  • Depression/physiopathology
  • Distance Counseling/methods
  • Female
  • Health Behavior/physiology
  • Health Promotion/methods
  • Humans
  • Male
  • Mental Health
  • Middle Aged
  • Primary Health Care/methods
  • Psychosocial Support Systems
  • Quality of Life

Cite this

@article{e6ad71371e5f4b0d80a7cef90a53771e,
title = "Multicentred randomised controlled trial of an augmented exercise referral scheme using web-based behavioural support in individuals with metabolic, musculoskeletal and mental health conditions: protocol for the e-coachER trial",
abstract = "INTRODUCTION: Physical activity is recommended for improving health among people with common chronic conditions such as obesity, diabetes, hypertension, osteoarthritis and low mood. One approach to promote physical activity is via primary care exercise referral schemes (ERS). However, there is limited support for the effectiveness of ERS for increasing long-term physical activity and additional interventions are needed to help patients overcome barriers to ERS uptake and adherence.This study aims to determine whether augmenting usual ERS with web-based behavioural support, based on the LifeGuide platform, will increase long-term physical activity for patients with chronic physical and mental health conditions, and is cost-effective.METHODS AND ANALYSIS: A multicentre parallel two-group randomised controlled trial with 1:1 individual allocation to usual ERS alone (control) or usual ERS plus web-based behavioural support (intervention) with parallel economic and mixed methods process evaluations. Participants are low active adults with obesity, diabetes, hypertension, osteoarthritis or a history of depression, referred to an ERS from primary care in the UK.The primary outcome measure is the number of minutes of moderate-to-vigorous physical activity (MVPA) in ≥10 min bouts measured by accelerometer over 1 week at 12 months.We plan to recruit 413 participants, with 88{\%} power at a two-sided alpha of 5{\%}, assuming 20{\%} attrition, to demonstrate a between-group difference of 36-39 min of MVPA per week at 12 months. An improvement of this magnitude represents an important change in physical activity, particularly for inactive participants with chronic conditions.ETHICS AND DISSEMINATION: Approved by North West Preston NHS Research Ethics Committee (15/NW/0347). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals.Results will be disseminated to ERS services, primary healthcare providers and trial participants.TRIAL REGISTRATION NUMBER: ISRCTN15644451; Pre-results.",
keywords = "Activities of Daily Living/psychology, Chronic Disease/psychology, Depression/physiopathology, Distance Counseling/methods, Female, Health Behavior/physiology, Health Promotion/methods, Humans, Male, Mental Health, Middle Aged, Primary Health Care/methods, Psychosocial Support Systems, Quality of Life",
author = "{Trial Steering Committee} and Wendy Ingram and Douglas Webb and Taylor, {Rod S} and Nana Anokye and Lucy Yardley and Kate Jolly and Nanette Mutrie and Campbell, {John L} and Dean, {Sarah Gerard} and Colin Greaves and Mary Steele and Lambert, {Jeffrey D} and Chloe McAdam and Ben Jane and Jennie King and Jones, {Ray B} and Paul Little and Anthony Woolf and Jo Erwin and Nigel Charles and Terry, {Rohini H} and Taylor, {Adrian H}",
note = "{\circledC} Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ.",
year = "2018",
month = "9",
day = "21",
doi = "10.1136/bmjopen-2018-022382",
language = "English",
volume = "8",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "9",

}

TY - JOUR

T1 - Multicentred randomised controlled trial of an augmented exercise referral scheme using web-based behavioural support in individuals with metabolic, musculoskeletal and mental health conditions

T2 - protocol for the e-coachER trial

AU - Trial Steering Committee

AU - Ingram, Wendy

AU - Webb, Douglas

AU - Taylor, Rod S

AU - Anokye, Nana

AU - Yardley, Lucy

AU - Jolly, Kate

AU - Mutrie, Nanette

AU - Campbell, John L

AU - Dean, Sarah Gerard

AU - Greaves, Colin

AU - Steele, Mary

AU - Lambert, Jeffrey D

AU - McAdam, Chloe

AU - Jane, Ben

AU - King, Jennie

AU - Jones, Ray B

AU - Little, Paul

AU - Woolf, Anthony

AU - Erwin, Jo

AU - Charles, Nigel

AU - Terry, Rohini H

AU - Taylor, Adrian H

N1 - © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ.

PY - 2018/9/21

Y1 - 2018/9/21

N2 - INTRODUCTION: Physical activity is recommended for improving health among people with common chronic conditions such as obesity, diabetes, hypertension, osteoarthritis and low mood. One approach to promote physical activity is via primary care exercise referral schemes (ERS). However, there is limited support for the effectiveness of ERS for increasing long-term physical activity and additional interventions are needed to help patients overcome barriers to ERS uptake and adherence.This study aims to determine whether augmenting usual ERS with web-based behavioural support, based on the LifeGuide platform, will increase long-term physical activity for patients with chronic physical and mental health conditions, and is cost-effective.METHODS AND ANALYSIS: A multicentre parallel two-group randomised controlled trial with 1:1 individual allocation to usual ERS alone (control) or usual ERS plus web-based behavioural support (intervention) with parallel economic and mixed methods process evaluations. Participants are low active adults with obesity, diabetes, hypertension, osteoarthritis or a history of depression, referred to an ERS from primary care in the UK.The primary outcome measure is the number of minutes of moderate-to-vigorous physical activity (MVPA) in ≥10 min bouts measured by accelerometer over 1 week at 12 months.We plan to recruit 413 participants, with 88% power at a two-sided alpha of 5%, assuming 20% attrition, to demonstrate a between-group difference of 36-39 min of MVPA per week at 12 months. An improvement of this magnitude represents an important change in physical activity, particularly for inactive participants with chronic conditions.ETHICS AND DISSEMINATION: Approved by North West Preston NHS Research Ethics Committee (15/NW/0347). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals.Results will be disseminated to ERS services, primary healthcare providers and trial participants.TRIAL REGISTRATION NUMBER: ISRCTN15644451; Pre-results.

AB - INTRODUCTION: Physical activity is recommended for improving health among people with common chronic conditions such as obesity, diabetes, hypertension, osteoarthritis and low mood. One approach to promote physical activity is via primary care exercise referral schemes (ERS). However, there is limited support for the effectiveness of ERS for increasing long-term physical activity and additional interventions are needed to help patients overcome barriers to ERS uptake and adherence.This study aims to determine whether augmenting usual ERS with web-based behavioural support, based on the LifeGuide platform, will increase long-term physical activity for patients with chronic physical and mental health conditions, and is cost-effective.METHODS AND ANALYSIS: A multicentre parallel two-group randomised controlled trial with 1:1 individual allocation to usual ERS alone (control) or usual ERS plus web-based behavioural support (intervention) with parallel economic and mixed methods process evaluations. Participants are low active adults with obesity, diabetes, hypertension, osteoarthritis or a history of depression, referred to an ERS from primary care in the UK.The primary outcome measure is the number of minutes of moderate-to-vigorous physical activity (MVPA) in ≥10 min bouts measured by accelerometer over 1 week at 12 months.We plan to recruit 413 participants, with 88% power at a two-sided alpha of 5%, assuming 20% attrition, to demonstrate a between-group difference of 36-39 min of MVPA per week at 12 months. An improvement of this magnitude represents an important change in physical activity, particularly for inactive participants with chronic conditions.ETHICS AND DISSEMINATION: Approved by North West Preston NHS Research Ethics Committee (15/NW/0347). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals.Results will be disseminated to ERS services, primary healthcare providers and trial participants.TRIAL REGISTRATION NUMBER: ISRCTN15644451; Pre-results.

KW - Activities of Daily Living/psychology

KW - Chronic Disease/psychology

KW - Depression/physiopathology

KW - Distance Counseling/methods

KW - Female

KW - Health Behavior/physiology

KW - Health Promotion/methods

KW - Humans

KW - Male

KW - Mental Health

KW - Middle Aged

KW - Primary Health Care/methods

KW - Psychosocial Support Systems

KW - Quality of Life

U2 - 10.1136/bmjopen-2018-022382

DO - 10.1136/bmjopen-2018-022382

M3 - Article

VL - 8

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 9

M1 - e022382

ER -