TY - JOUR
T1 - A novel, multidomain, primary care nurse-led and mHealth-assisted intervention for dementia risk reduction in middle-aged adults (HAPPI MIND)
T2 - study protocol for a cluster randomised controlled trial
AU - Cross, Amanda J.
AU - Geethadevi, Gopisankar Mohanannair
AU - Magin, Parker
AU - Baker, Amanda L.
AU - Bonevski, Billie
AU - Godbee, Kali
AU - Ward, Stephanie A.
AU - Mahal, Ajay
AU - Versace, Vincent
AU - Bell, J. Simon
AU - Mc Namara, Kevin
AU - O'Reilly, Sharleen L.
AU - Thomas, Dennis
AU - Manias, Elizabeth
AU - Anstey, Kaarin J.
AU - Varnfield, Marlien
AU - Jayasena, Rajiv
AU - Elliott, Rohan A.
AU - Lee, Cik Y.
AU - Walker, Christine
AU - van den Bosch, Denise
AU - Tullipan, Mary
AU - Ferreira, Catherine
AU - George, Johnson
PY - 2023/12/19
Y1 - 2023/12/19
N2 - INTRODUCTION: Middle-aged multidomain risk reduction interventions targeting modifiable risk factors for dementia may delay or prevent a third of dementia cases in later life. We describe the protocol of a cluster randomised controlled trial (cRCT), HAPPI MIND (Holistic Approach in Primary care for PreventIng Memory Impairment aNd Dementia). HAPPI MIND will evaluate the efficacy of a multidomain, nurse-led, mHealth supported intervention for assessing dementia risk and reducing associated risk factors in middle-aged adults in the Australian primary care setting. METHODS AND ANALYSIS: General practice clinics (n≥26) across Victoria and New South Wales, Australia, will be recruited and randomised. Practice nurses will be trained to implement the HAPPI MIND intervention or a brief intervention. Patients of participating practices aged 45-65 years with ≥2 potential dementia risk factors will be identified and recruited (approximately 15 patients/clinic). Brief intervention participants receive a personalised report outlining their risk factors for dementia based on Australian National University Alzheimer's Disease Risk Index (ANU-ADRI) scores, education booklet and referral to their general practitioner as appropriate. HAPPI MIND participants receive the brief intervention as well as six individualised dementia risk reduction sessions with a nurse trained in motivational interviewing and principles of behaviour change, a personalised risk reduction action plan and access to the purpose-built HAPPI MIND smartphone app for risk factor self-management. Follow-up data collection will occur at 12, 24 and 36 months. Primary outcome is ANU-ADRI score change at 12 months from baseline. Secondary outcomes include change in cognition, quality of life and individual risk factors of dementia. ETHICS AND DISSEMINATION: Project approved by Monash University Human Research Ethics Committee (ID: 28273). Results will be disseminated in peer-reviewed journals and at healthcare conferences. If effective in reducing dementia risk, the HAPPI MIND intervention could be integrated into primary care, scaled up nationally and sustained over time. TRIAL REGISTRATION NUMBER: ACTRN12621001168842.
AB - INTRODUCTION: Middle-aged multidomain risk reduction interventions targeting modifiable risk factors for dementia may delay or prevent a third of dementia cases in later life. We describe the protocol of a cluster randomised controlled trial (cRCT), HAPPI MIND (Holistic Approach in Primary care for PreventIng Memory Impairment aNd Dementia). HAPPI MIND will evaluate the efficacy of a multidomain, nurse-led, mHealth supported intervention for assessing dementia risk and reducing associated risk factors in middle-aged adults in the Australian primary care setting. METHODS AND ANALYSIS: General practice clinics (n≥26) across Victoria and New South Wales, Australia, will be recruited and randomised. Practice nurses will be trained to implement the HAPPI MIND intervention or a brief intervention. Patients of participating practices aged 45-65 years with ≥2 potential dementia risk factors will be identified and recruited (approximately 15 patients/clinic). Brief intervention participants receive a personalised report outlining their risk factors for dementia based on Australian National University Alzheimer's Disease Risk Index (ANU-ADRI) scores, education booklet and referral to their general practitioner as appropriate. HAPPI MIND participants receive the brief intervention as well as six individualised dementia risk reduction sessions with a nurse trained in motivational interviewing and principles of behaviour change, a personalised risk reduction action plan and access to the purpose-built HAPPI MIND smartphone app for risk factor self-management. Follow-up data collection will occur at 12, 24 and 36 months. Primary outcome is ANU-ADRI score change at 12 months from baseline. Secondary outcomes include change in cognition, quality of life and individual risk factors of dementia. ETHICS AND DISSEMINATION: Project approved by Monash University Human Research Ethics Committee (ID: 28273). Results will be disseminated in peer-reviewed journals and at healthcare conferences. If effective in reducing dementia risk, the HAPPI MIND intervention could be integrated into primary care, scaled up nationally and sustained over time. TRIAL REGISTRATION NUMBER: ACTRN12621001168842.
KW - Clinical Trial
KW - Dementia
KW - Patient-Centered Care
KW - PREVENTIVE MEDICINE
KW - Primary Health Care
KW - PUBLIC HEALTH
UR - http://www.scopus.com/inward/record.url?scp=85180385097&partnerID=8YFLogxK
UR - http://purl.org/au-research/grants/NHMRC/1171851
U2 - 10.1136/bmjopen-2023-073709
DO - 10.1136/bmjopen-2023-073709
M3 - Article
C2 - 38114278
AN - SCOPUS:85180385097
SN - 2044-6055
VL - 13
JO - BMJ Open
JF - BMJ Open
IS - 12
M1 - e073709
ER -
