Lifestyle Matters for maintenance of health and wellbeing in people aged 65 years and over: study protocol for a randomised controlled trial.
BACKGROUND
Healthy, active ageing is strongly associated with good mental wellbeing which in turn helps to prevent mental illness. However, more investment has been made into research into interventions to prevent mental illness than into those designed to improve mental wellbeing. This applied research programme will provide high quality evidence for an intervention designed to improve and sustain mental wellbeing in older adults.


METHODS
This study was a multi-centre, pragmatic, two-arm, parallel group, individually randomised controlled trial to determine the population benefit of an occupational therapy based intervention for community living people aged 65 years or older. Participants (n = 268) will be identified in one city in the North of England and in North Wales through GP mail-outs, signposting by local authority, primary care staff and voluntary sector organisations and through community engagement. Participants will be randomised to one of two treatment arms: an intervention (Lifestyle Matters programme); or control (routine access to health and social care). All participants will be assessed at baseline, 6 and 24 months post-randomisation. The primary outcome, which is a person reported outcome, is the SF-36 Mental Health dimension at six months post randomisation. Secondary outcome measures have been selected to measure psychosocial, physical and mental health outcomes. They include other dimensions of the SF36, EQ-5D-3L, Brief Resilience Scale, General Perceived Self Efficacy Scale, PHQ-9, de Jong Gierveld Loneliness Scale, Health and Social Care Resource Use and the wellbeing question of the Integrated Household Survey 2011. A cost effectiveness analysis will investigate the incremental cost per Quality Adjusted Life Years (QALYs) of the Lifestyle Matters intervention compared with treatment as usual.


CONCLUSIONS
The questions being posed through this research are important given the increasing numbers of older people, pressure on the public purse and the associated need to support good health in the extended lifespan. The proposed trial will determine the clinical and cost effectiveness of the intervention delivered in a UK context. The results will support commissioners and providers with decisions about implementation.


BACKGROUND
Current Controlled Trials ISRCTN67209155.
School of Health and Related Research (ScHARR), University of Sheffield, Regent Court, Regent Street, Sheffield S1 4DA, England, UK. k.sprange@sheffield.ac.uk.
Kirsty
K
Sprange
Gail A
GA
Mountain
John
J
Brazier
Sarah P
SP
Cook
Claire
C
Craig
Daniel
D
Hind
Stephen J
SJ
Walters
Gill
G
Windle
Robert
R
Woods
Anju D
AD
Keetharuth
Tim
T
Chater
Kath
K
Horner
D000367:Age Factors; D000368:Aged; D000375:Aging / Q000523:psychology*; D003153:Community Health Services / Q000191:economics; D003362:Cost-Benefit Analysis; D004739:England; D015577:Geriatric Assessment; D017048:Health Care Costs; D006299:Health Services for the Aged / Q000191:economics; D006801:Humans; D008019:Life Style; D008603:Mental Health; D009788:Occupational Therapy / Q000191:economics; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D014852:Wales