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Trial registered on ANZCTR


Registration number
ACTRN12616000685415
Ethics application status
Approved
Date submitted
9/04/2016
Date registered
25/05/2016
Date last updated
7/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Older people in retirement villages: unidentified need & intervention research
Scientific title
Older people in retirement villages: unidentified need & intervention research
Secondary ID [1] 288944 0
None
Universal Trial Number (UTN)
U1111-1173-6083
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
aged care 298305 0
hospitalistion 298306 0
multiple cormorbidity 298309 0
Condition category
Condition code
Public Health 298431 298431 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We believe that older retirement village ('village') residents may have multiple unmet need and high healthcare utilisation, and targeted intervention will decrease long term care entry & acute hospitalisation. We will evaluate an integrated care package to increase care coordination results for NZ.
The trial will have three phases. Phase 1: Residents will complete a questionnaire about their health and functional items. The main purpose is to describe the health and functional needs of residents. Phase 2: All participants will be followed for three-six years from the survey date using Ministry of Health routinely collected data on healthcare usage. Survey interviews will be repeated at 12, 24 and 48 months. The main purpose of this phase is to describe trajectories of health-care service utilisation and identify resident clusters by baseline characteristics and trajectories. Phase 3 (randomised controlled trial) : Based on results from BRIGHT (ACTRN12609000648224) and ARCHIP (ACTRN12614000499684) study criteria we will select a sub-sample of residents (about 40%) ‘at high risk’ of health and functional decline from phase 1’s sample. A multidisciplinary team (MDT) led by gerontology nurse specialist (GNS) will (in the intervention group of residents) complete a comprehensive geriatric assessment develop/ implement an intervention plan in collaboration with the older person & their nominated support person(s), geriatrician, village staff, physiotherapist, occupational therapist & clinical pharmacist (with standard clinical application of the STOPP/START criteria). This will necessitate an initial consultation with between the GNS and the older person and their nominated support person (if the older person desires) of approximately 1 hours' duration. Treatment goals will be developed, and the GNS & MDT will record interventions in a computerized log and in the participant's hospital-based clinical record (with letters to the general practitioner). GNS will meet regularly with MDT: GPs will be invited to attend - if unable the GNS will liaise in writing and in-person. Intervention duration (not <6 months - duration decided by GNS/MDT/GP by consensus and based on perception of clinical need - this is likely to involve regular consultations between the GNS and the older person) approximately every 3 months (though this will vary from person to person) in order to monitor clinical progress - again with record of consultation and recommended interventions in a computerized log and in the participant's hospital-based clinical record (with letters to the general practitioner) will be person-specific be followed by open-ended clinical GNS support from the hospital based GNS service - as dictated by standard clinical need. The General Practitioner will continue to have overall charge of the participant's care and will be free to accept/modify/reject MDT/GNS recommendations (as per ARCHIP). The intervention will be tested by cluster-RCT of usual care vs. intervention. The ‘high risk’ intervention and control groups will have assessments repeated at the end of first and second years.
Intervention code [1] 294421 0
Early detection / Screening
Intervention code [2] 294448 0
Prevention
Intervention code [3] 294449 0
Treatment: Other
Comparator / control treatment
Phase 1 and 2 (above) will have no control group (as these phases are observational only)

Phase 3 (randomised controlled trial): 'control' residents will receive best practice usual care. This comprises standard general practitioner care together with full access to secondary care referral and provision, including clinical appropriate Gerontology Nurse Practitioner assessment and support
Control group
Active

Outcomes
Primary outcome [1] 297920 0
hospital emergency department presentations by data linkage to Ministry of Health (MoH) records.

This outcome relates to Phases 2 and 3 of the study
Timepoint [1] 297920 0
MoH databases will be searched 1 year pre- and 1, 2 & 4 years post-intervention and (pending further funding) also at 6 years. We will evaluate endpoints at all these periods but for Phase 3 (in view of results from ARCHIP - submitted for publication) we are particularly interested in the duration of any beneficial effect . Thus at 1- year interrogation of the MOH data base our statistical model will examine the effect at 12 months..


Primary outcome [2] 297921 0
avoidable hospital admissions by data linkage to Ministry of Health (MoH) records.

This outcome relates to Phases 2 and 3 of the study
Timepoint [2] 297921 0
MoH databases will be searched 1 year pre- and 1, 2 & 4 years post-intervention and (pending further funding) also at 6 years. We will evaluate endpoints at all these periods but for Phase 3 (in view of results from ARCHIP - submitted for publication) we are particularly interested in the duration of any beneficial effect.which we anticipate may be 6-9 months. Thus at 1- year interrogation of the MOH data base our statistical model will examine not only the effect at 12 months but also any effects up to 6-9 months post intervention.
Secondary outcome [1] 322634 0
mortality by data linkage to Ministry of Health (MoH) records.

This outcome relates to Phases 2 and 3 of the study
Timepoint [1] 322634 0
MoH databases will be searched 1 year pre- and 1, 2 & 4 years post-intervention and (pending further funding) also at 6 years. We will evaluate endpoints at all these periods but for Phase 3 (in view of results from ARCHIP - submitted for publication) we are particularly interested in the duration of any beneficial effect.which we anticipate may be 6-9 months. Thus at 1- year interrogation of the MOH data base our statistical model will examine not only the effect at 12 months but also any effects up to 6-9 months post intervention.
Secondary outcome [2] 322635 0
all hospitalisations by data linkage to Ministry of Health (MoH) records.

This outcome relates to Phases 2 and 3 of the study
Timepoint [2] 322635 0
MoH databases will be searched 1 year pre- and 1, 2 & 4 years post-intervention and (pending further funding) also at 6 years. We will evaluate endpoints at all these periods but for Phase 3 (in view of results from ARCHIP - submitted for publication) we are particularly interested in the duration of any beneficial effect.which we anticipate may be 6-9 months. Thus at 1- year interrogation of the MOH data base our statistical model will examine not only the effect at 12 months but also any effects up to 6-9 months post intervention.
Secondary outcome [3] 322858 0
RAC admission by data linkage to Ministry of Health (MoH) records.

This outcome relates to Phases 2 and 3 of the study
Timepoint [3] 322858 0
MoH databases will be searched 1 year pre- and 1, 2 & 4 years post-intervention and (pending further funding) also at 6 years. We will evaluate endpoints at all these periods but for Phase 3 (in view of results from ARCHIP - submitted for publication) we are particularly interested in the duration of any beneficial effect which we anticipate may be 6-9 months. Thus at 1- year interrogation of the MOH data base our statistical model will examine not only the effect at 12 months but also any effects up to 6-9 months post intervention.
Secondary outcome [4] 322859 0
Quality of life by repeated (abbreviated) questionnaires (designed specifically for this study) of study subjects.

This outcome related to Phases 2 and 3 of the study
Timepoint [4] 322859 0
1, 2 and 4 years and (pending further funding) also at 6 years.

Eligibility
Key inclusion criteria
Older residents of retirement villages (RVs) in Auckland and Waitemata District Health Board catchments. No lower age definition is included, partly as Maori people on average develop morbidity and co-morbidity many years earlier than those of European ethnicity, but in practice almost all RV residents are aged 65+ years and most are aged 75+ years
Minimum age
55 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
[1] Those declining informed consent

[2] Those in whom ACER (cognitive score) is less than 65 or for whom there is suspicion (from their General Practitioner or from the research team) that they lack legal capacity (most commonly by virtue of chronic cognitive impairment) to consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Phases 1 and 2 of the study are observational only.
Phase 3 is an RCT

For Phase 3 allocation and concealment will be by central randomization by computer to which the investigators involved outcome collection have no access
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification by stratified by RV size, ownership, location (rural/urban)

Randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
In addition to simple descriptive statistics we will use Phase 2 outcomes to statistically model baseline (Phase 1) variables and produce, for control subjects (those not in Phase 3 intervention group), independent predictors of service utilisation/ mortality in order to compare these against current predictors.

1o outcome (Phase 3) : acute hospitalisation assessed by time to event analysis (i.e. continuous time endpoints) 2o outcomes Phase 3): RAC admission or death, functional ability, QoL, assessed by time to event analysis. Power (Phase 3): Assuming 600 people are assessed high risk & randomised: if the risk of >1 acute hospitalisation is 26% p.a. (guided by previous data from our own studies - Broad et al 2014; Broad et al, submitted March 2015; Boyd et al, in preparation) and risk of RAC entry or death is 15% p.a. (Heppenstall, et al 2015) and allowing for design effect of 1.5 (Connolly et al 2015b) this yields for example 93% power for 20% difference in hospitalisation (3yrs) & for example 80% power for 30% difference in RAC admission or death (3yrs). Further follow-up: 6 years - subject to separate grant application.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7799 0
New Zealand
State/province [1] 7799 0

Funding & Sponsors
Funding source category [1] 293322 0
University
Name [1] 293322 0
University of Otago (National Science Challenge - Ageing Well)
Address [1] 293322 0
Ageing Well National Science Challenge, School of Physiotherapy, University of Otago, PO Box 56, Dunedin 9054, New Zealand


Country [1] 293322 0
New Zealand
Funding source category [2] 293323 0
Government body
Name [2] 293323 0
Waitema District Health Board
Address [2] 293323 0
University Department of Geriatric Medicine,,
North Shore Hospital,
Waitemata District Health Board
Shakespeare Rd
Takapuna
Auckland
New Zealand 0622
Country [2] 293323 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Medicine
Room 12-073D, Support Building, Auckland Hospital
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand

Country
New Zealand
Secondary sponsor category [1] 292136 0
None
Name [1] 292136 0
Address [1] 292136 0
Country [1] 292136 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294794 0
HDEC (New Zealand)
Ethics committee address [1] 294794 0
Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 294794 0
New Zealand
Date submitted for ethics approval [1] 294794 0
Approval date [1] 294794 0
01/04/2016
Ethics approval number [1] 294794 0
16/CEN/34

Summary
Brief summary
Retirement Villages (RVs) have, the the past 20 years or more become a very popular lifestyle choice for older people in New Zealand and elsewhere. On average RV residents are aged 75 years or more, but little is known about them as a group in terms of their medical and other needs and their functional abilities and disabilities, or about how these progress over time. This study aims to recruit 1500 older Auckland RV residents as volunteers, and by means of an interview and/or questionnaire, to gather such information about them. It also plans (with the volunteers;' permission) to 'follow' them over at least three years to see what happens to them in terms of their health, hospital admissions, moves to residential care (e.g rest homes) or mortality. The study will select approximately 600 of the 1500 residents for a research trial in which about half (i.e. about 300 people) will receive additional support (led buy a nurse specialist) to maintain their health and independence. The trial will examine whether this extra support helps reduce unfavorable 'events' such as hospital admissions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64998 0
Prof Martin Connolly
Address 64998 0
Auckland University Department of Geriatric Medicine, Level 1, Building 5, North Shore Hospital Waitemata District Health Board Shakespeare Rd Takapuna Auckland, New Zealand 0622
Country 64998 0
New Zealand
Phone 64998 0
+64 (0)9 442 7146
Fax 64998 0
+64 (0)9 442 7166
Email 64998 0
martin.connolly@waitematadhb.govt.nz
Contact person for public queries
Name 64999 0
Prof Martin Connolly
Address 64999 0
Auckland University Department of Geriatric Medicine, Level 1, Building 5, North Shore Hospital Waitemata District Health Board Shakespeare Rd Takapuna Auckland, New Zealand 0622
Country 64999 0
New Zealand
Phone 64999 0
+64 (0)9 442 7146
Fax 64999 0
+64 (0)9 442 7166
Email 64999 0
martin.connolly@waitematadhb.govt.nz
Contact person for scientific queries
Name 65000 0
Prof Martin Connolly
Address 65000 0
Auckland University Department of Geriatric Medicine
North Shore Hospital
Waitemata District Health Board
Shakespeare Rd
Takapuna
Auckland, New Zealand
0622
Country 65000 0
New Zealand
Phone 65000 0
+64 (0)9 442 7146
Fax 65000 0
+64 (0)9 442 7166
Email 65000 0
martin.connolly@waitematadhb.govt.nz

No information has been provided regarding IPD availability
Summary results
No Results