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Study protocol of a randomised controlled trial to examine the impact of a complex intervention in pre-frail older adults

  • Ruth TehEmail author
  • Ngaire Kerse
  • Debra L. Waters
  • Leigh Hale
  • Avinesh Pillai
  • Evelingi Leilua
  • Esther Tay
  • Anna Rolleston
  • Richard Edlin
  • Eruera Maxted
  • Claire Heppenstall
  • Martin J. Connolly
Original Article

Abstract

Background

Frailty is a multidimensional geriatric syndrome associated with functional loss. The Senior Chef (SC, nutrition) and SAYGO (strength and balance exercise) programmes are well accepted among older adults but the impact of each, or a combination of both, on the frailty syndrome in pre-frail older adults is unknown.

Aims

To determine the effectiveness and cost-effectiveness of a complex intervention consisting of the SC and/or SAYGO programmes to prevent progression of frailty in pre-frail older adults.

Methods

A multi-centre randomised controlled assessor-blinded study. The four intervention groups are SC, an 8-week nutrition education and cooking class; SAYGO, a 10-week strength and balance exercise class; SC plus SAYGO, and a social group (Control). Community-dwelling adults aged 75+ (60 + Māori and Pasifika) in New Zealand are recruited through health providers. Participants are not terminally ill or with advanced dementia, and have a score of 1 or 2 on the FRAIL questionnaire. Baseline assessments are completed using standardised questionnaires prior to randomisation. Four follow-up assessments are completed: immediately after intervention, 6, 12 and 24 months post-intervention. The primary outcome is frailty score, secondary outcomes are falls, physical function, quality of life, food intake, physical activity, and sustainability of the strategy. Study outcomes will be analysed using intention-to-treat approach. Cost analyses will be completed to determine if interventions are cost effective relative to the control group.

Discussion

This trial is designed to be a real world rigorous assessment of whether the two intervention strategies can prevent progression of frailty in older people. If successful, this will generate valuable information about effectiveness of this nutrition and exercise strategy, and provide insights for their implementation.

Trial registration

Australian and New Zealand Clinical Trials Registry number—ACTRN12614000827639.

Keywords

Frailty Nutrition Physical activity Older adults Cost effectiveness 

Notes

Acknowledgements

We would like to acknowledge the local Primary Healthcare Organizations (East Health Trust, Manaia Health, Western Bay of Plenty, and Well South) for engaging with the general practices for the recruitment, Margaret Dando from Age Concern Otago for providing training to the SAYGO facilitators, Older Person’s Health Canterbury District Health Board for providing training to the Senior Chef facilitators, the local stakeholders (Anglican Care Whangarei, Howick Communicare, Regent Community Trust 4Cs, Senior Citizens Whangarei and local Age Concern organisations) for being instrumental in delivery of the programme, the research coordinators for assisting with the recruitment and organizing the programmes, the assessors for completing the assessments diligently, the programme facilitators for delivering the programme and transitioning to peer-led groups, and the data quality assurance personnel (Frances Backhurst).

Author contributions

RT and NK conceived the study and obtained funding for the pilot study. RT, NK, DW, LH and AP were involved in the study design and obtained funding for the main study. RT, NK, DW, LH, AP, ET, ET, AR, RE, EM and MJC contributed in writing of the manuscript. All authors read and approved the final manuscript.

Funding

The pilot study is funded by the Health Research Council New Zealand and the main study is funded by the Ageing Well Challenge, Ministry of Business Innovation and Employment. Local supermarkets (Countdown Howick and New World Whangarei) provided partial funding for the Senior Chef Programme and selected local organizations supported hall hire cost. All the funding bodies are not involved in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no competing interests.

Ethics approval

The study is approved by the Southern Health and Disability Ethics Committee, Ministry of Health, New Zealand (Ref 14/STH/101/, 13th August 2014).

Informed consent

All participants provided written consent.

Consent for publication

Not applicable.

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Ruth Teh
    • 1
    Email author
  • Ngaire Kerse
    • 2
  • Debra L. Waters
    • 3
  • Leigh Hale
    • 4
  • Avinesh Pillai
    • 5
  • Evelingi Leilua
    • 1
  • Esther Tay
    • 1
  • Anna Rolleston
    • 6
  • Richard Edlin
    • 7
  • Eruera Maxted
    • 8
  • Claire Heppenstall
    • 9
  • Martin J. Connolly
    • 10
    • 11
  1. 1.Department of General Practice and Primary Health Care, School of Population HealthUniversity of AucklandAucklandNew Zealand
  2. 2.School of Population HealthUniversity of AucklandAucklandNew Zealand
  3. 3.Department of Medicine, School of PhysiotherapyUniversity of OtagoDunedinNew Zealand
  4. 4.Centre for Health, Activity and Rehabilitation Research, School of PhysiotherapyUniversity of OtagoDunedinNew Zealand
  5. 5.Department of Statistics, Faculty of ScienceUniversity of AucklandAucklandNew Zealand
  6. 6.The Centre of HealthTaurangaNew Zealand
  7. 7.Health Systems Group, School of Population HealthUniversity of AucklandAucklandNew Zealand
  8. 8.Lakes District Health BoardRotoruaNew Zealand
  9. 9.Department of MedicineUniversity of OtagoChristchurchNew Zealand
  10. 10.Department of Geriatric MedicineUniversity of AucklandAucklandNew Zealand
  11. 11.Waitemata District Health BoardAucklandNew Zealand

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