ITM support for patients with chronic respiratory and cardiovascular diseases: a protocol for a randomised controlled trial

Julie Redfern; Karice Hyun; Anna Singleton; Nashid Hafiz; Rebecca Raeside; Lissa Spencer; Bridie Carr; Ian Caterson; John Cullen; Cate Ferry; Karla Santo; Alison Hayes; Regina W M Leung; Simon Raadsma; Jessica Swinbourne; Jin G Cho; Meredith King; Mary Roberts; Cindy Kok; Christine Jenkins; Clara Chow

doi:10.1136/bmjopen-2018-023863

ITM support for patients with chronic respiratory and cardiovascular diseases: a protocol for a randomised controlled trial

BMJ Open. 2019 Mar 1;9(3):e023863. doi: 10.1136/bmjopen-2018-023863.

Authors

Julie Redfern^{1

2}, Karice Hyun¹, Anna Singleton¹, Nashid Hafiz¹, Rebecca Raeside¹, Lissa Spencer³, Bridie Carr⁴, Ian Caterson⁵, John Cullen⁶, Cate Ferry⁷, Karla Santo^{8

9}, Alison Hayes¹⁰, Regina W M Leung¹¹, Simon Raadsma¹², Jessica Swinbourne¹³, Jin G Cho¹⁴, Meredith King¹⁵, Mary Roberts¹⁶, Cindy Kok¹⁴, Christine Jenkins¹⁷, Clara Chow^{1

16}

Affiliations

¹ Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
² Cardiovascular Division, The George Institute for Global Health, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
³ Department of Physiotherapy, Sydney Local Health District, Camperdown, New South Wales, Australia.
⁴ NSW Agency for Clinical Innovation, Sydney, New South Wales, Australia.
⁵ Boden Institute, University of Sydney, University of Sydney, New South Wales, Australia.
⁶ Department of Geriatric Medicine, Concord Repatriation General Hospital, Sydney LHD, Sydney, New South Wales, Australia.
⁷ NSW Division, Heart Foundation, Sydney, New South Wales, Australia.
⁸ Cardiovascular Division, The George Institute for Global Health, Sydney, New South Wales, Australia.
⁹ Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
¹⁰ School of Public Health, University of Sydney, Sydney, Australia.
¹¹ Faculty of Health Sciences, University of Sydney, Sydney, New South Wales, Australia.
¹² Behavioural Insights Unit, NSW Department of Premier and Cabinet, Sydney, New South Wales, Australia.
¹³ Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Sydney, New South Wales, Australia.
¹⁴ Westmead Clinical School, University of Sydney, Sydney, New South Wales, Australia.
¹⁵ Chronic Disease Community Rehabilitation Service, Northern Sydney Local Health District, Sydney, New South Wales, Australia.
¹⁶ Western Sydney Local Health District, Westmead, New South Wales, Australia.
¹⁷ Institute of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.

Abstract

Introduction: Simple and scalable strategies are needed to improve 'out-of-hospital' support and management for people living with cardiovascular disease (CVD) and respiratory disease. Text messaging via mobile phones has been shown to be effective in helping promote lifestyle change and is supported by quantitative and qualitative evidence. The aim of this study is to test the effectiveness and implementation of a 6-month text messaging support programme for people with CVD and respiratory disease as an addition to cardiac and pulmonary outpatient rehabilitation.

Methods and analysis: Pragmatic randomised controlled trial (n=310) to test the effectiveness of a 6-month text message support programme on clinical outcomes in people with CVD and chronic respiratory disease who are attending outpatient cardiac and pulmonary rehabilitation. The study includes a nested process evaluation to inform scalability and implementation across settings. The intervention group will receive a text message support programme comprising five messages per week for 26 weeks and the control group will continue with standard care. The primary outcome is exercise capacity (6 min walk distance). Secondary outcomes include clinical measures (proportion of people meeting the Australian guideline-recommended blood pressure and cholesterol targets), lifestyle outcomes (smoking rates, achievement of national guidelines for nutrition and physical activity), quality of life, mood (Hospital Anxiety and Depression Scale), medication adherence and attendance at and completion of rehabilitation.

Ethics and dissemination: Primary ethics approval was received from the Sydney Local Health District Hospital Human Research Ethics Committee and associated Governance committees at sites. Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferences. At its conclusion, the study will determine the effectiveness and implementation of a simple programme that aims to improve health outcomes and attendance at rehabilitation for people with CVD and chronic respiratory disease.

Trial registration number: ACTRN12616001167459.

Keywords: cardiovascular disease; chronic obstructive pulmonary disease; implementation; rehabilitation medicine; respiratory medicine (see thoracic medicine); text message.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Australia
Blood Pressure
Cardiovascular Diseases / therapy*
Cell Phone
Chronic Disease
Diet
Exercise
Humans
Life Style
Medication Adherence*
Motivation
Patient Education as Topic / methods*
Pragmatic Clinical Trials as Topic
Quality of Life
Reminder Systems
Respiratory Tract Diseases / therapy*
Self Care / methods
Text Messaging*

Associated data

ANZCTR/ACTRN12616001167459