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Movement through Active Personalised engagement (MAP) - a self-management programme designed to promote physical activity in people with multimorbidity: study protocol for a randomised controlled trial.

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posted on 2019-08-20, 08:52 authored by H Dallosso, T Yates, H Mani, LJ Gray, N Dhalwani, E Baldry, C Gillies, S Cradock, M Batt, MJ Davies, K Khunti
BACKGROUND: Multimorbidity, defined as two or more concurrent chronic diseases within the same individual, is becoming the clinical norm within primary care. Given the burden of multimorbidity on individuals, carers and health care systems, there is a need for effective self-management programmes. Promoting active participation within their clinical care and following a healthy lifestyle will help empower patients and target lifestyle factors that are exacerbating their conditions. The aim of this study is to establish whether a tailored, structured self-management programme can improve levels of physical activity at 12 months, in people with multimorbidity. METHODS/DESIGN: This study is a single-centre randomised controlled trial, with follow-up at 6 and 12 months. The primary outcome is change in objectively assessed average daily physical activity at 12 months. Secondary outcomes include medication adherence, lifestyle behaviours, quality of life, chronic disease self-efficacy and self-efficacy for exercise. Anthropometric and clinical measurements include blood pressure, muscle strength, lipid profile, kidney function and glycated haemoglobin (HbA1c). Participants are recruited from primary care. Those between 40 and 85 years of age with multimorbidity, with a good understanding of written and verbal English, who are able to give informed consent, have access to a mobile phone for use in study activities and are able to walk independently will be invited to participate. Multimorbidity is defined as two or more of the chronic conditions listed in the Quality and Outcomes Framework. A total of 338 participants will be randomly assigned, with stratification for gender and ethnicity, to either the control group, receiving usual care, or the intervention group, who are invited to the Movement through Active Personalised engagement programme. This involves attending four group-based self-management sessions aimed at increasing physical activity, mastering emotions, managing treatments and using effective communication. The sessions are delivered by trained facilitators, and regular text messages during the study period provide ongoing support. Changes in primary and secondary outcomes will be assessed, and an economic evaluation of the intervention undertaken. DISCUSSION: This study will provide new evidence on whether physical activity can be promoted alongside other self-management strategies in a multimorbid population and whether this leads to improvements in clinical, biomedical, psychological and quality of life outcomes. TRIAL REGISTRATION: ISRCTN, ISRCTN 42791781 . Registered on 14 March 2017.

Funding

The research is funded by the NIHR CLAHRC East Midlands and the East Midlands Academic Health Science Network. The protocol was reviewed by an external scientific review committee before the funding was confirmed. The views expressed in the paper are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

History

Citation

Trials, 2018, 19, Article number: 576

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Department of Health Sciences

Version

  • VoR (Version of Record)

Published in

Trials

Publisher

BMC (part of Springer Nature)

eissn

1745-6215

Acceptance date

2018-09-26

Copyright date

2018

Available date

2019-08-20

Publisher version

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2939-2

Notes

The datasets generated and/or analysed during the current study are not expected to be made publicly available due to ethical restrictions. An anonymised minimal dataset will be made available to bonafide researchers interested in collaborative research through requests sent to the lead author.

Language

en

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