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Trial registered on ANZCTR


Registration number
ACTRN12618000766213
Ethics application status
Approved
Date submitted
2/05/2018
Date registered
7/05/2018
Date last updated
12/11/2021
Date data sharing statement initially provided
21/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacist service to reduce side effects of medicines in older people in aged care
Scientific title
Pharmacist-led service to reduce medicine-induced deterioration and adverse reactions in older people living in residential aged care facilities
Secondary ID [1] 293583 0
None
Universal Trial Number (UTN)
U1111-1213-2859
Trial acronym
ReMInDAR Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function
 307695 0
Physical function 312871 0
Frailty 312872 0
Adverse events 312873 0
Condition category
Condition code
Public Health 306759 306759 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ‘intervention’ is a 12-month pharmacist led assessment of signs and symptoms of medicine-induced deterioration and adverse medicine events. The intervention group will receive a sessional pharmacist-led assessment which occurs every 8 weeks.

The service includes assessment for adverse medicine events and medicine-induced deterioration including assessment of cognition (using the Montreal Cognitive Assessment (MoCA)), 24-hour movement behaviour including sleep (Activinsights Bands, Activinsights Ltd, Cambridgeshire, UK fitted for one year), and hand grip strength (dynamometer, Jamar, Illinois, USA).

During the visit, the pharmacists will review participant care records to identify any new illnesses or conditions present since the last assessment. The pharmacists will review the care record to identify any adverse events (e.g. falls, delirium events, bowel or urinary changes, weight loss) or any signs or symptoms noted in the care record that could be indicative of adverse events (e.g. changes in nutritional status, pain). The pharmacists will also access the medication chart to identify any medication changes that have occurred since the last visit.

The pharmacist service also involves discussions with the participants and care staff to identify any concerns. The pharmacists will compare the results for the 24 hour movement behaviour, MoCA test, grip strength and weight with the most recent previous assessment and with baseline data to identify immediate and cumulative changes in each category.

Where medicine-induced deterioration is detected in the intervention-group participants and considered serious, the pharmacists will contact the participants’ GPs to discuss the participants’ condition, fill out a report to the GP including recommended actions and follow-up with the GP and facility staff. The pharmacists will reassess the participant at the next sessional visit to determine if medicine-induced deterioration or adverse events have resolved.
Intervention code [1] 301086 0
Prevention
Comparator / control treatment
The comparator cohort will receive usual care provided under the existing pharmacist
service. Usual care refers to the annual or biennial Residential Medication Management Reviews (RMMR) provided to residents in approved Australian Government funded aged care facilities,
These services will still be available to the intervention and control group during this time.
Control group
Active

Outcomes
Primary outcome [1] 305747 0
Change in frailty level as assessed using the frailty index
Timepoint [1] 305747 0
Baseline, 6-months post-baseline, 12 months post-baseline (primary endpoint)
Secondary outcome [1] 346349 0
Change in cognitive function as measures using the Montreal Cognitive Assessment (MoCA)
Timepoint [1] 346349 0
Baseline, 6-months post-baseline, 12 months post-baseline
Secondary outcome [2] 346350 0
Change in 24 hour movement behaviour (sleep time) as measured using GENEActiv activity tracker
Timepoint [2] 346350 0
Baseline, 6-months post-baseline, 12 months post-baseline
Secondary outcome [3] 346351 0
Grip strength (dynamometer)
Timepoint [3] 346351 0
Baseline, 6-months post-baseline, 12 months post-baseline
Secondary outcome [4] 346352 0
Change in weight as measured using a digital scale
Timepoint [4] 346352 0
Baseline, 6-months post-baseline, 12 months post-baseline
Secondary outcome [5] 346353 0
Change in percentage of robust, pre-frail and frail individuals as measured using the frailty phenotype. The frailty phenotype comprises five criteria: unintentional weight loss, low grip strength, self-rated exhaustion, low walking time and low physical activity. In the frailty phenotype, individuals are classified as frail if they meet three or more of the five criteria, and pre-fail if they have one or two attributes. Individuals who meet none of the criteria are classified as robust.
Timepoint [5] 346353 0
Baseline, 6-months post-baseline, 12 months post-baseline
Secondary outcome [6] 346354 0
Rate of adverse medicine events (such as falls, fractures, delirium, faecal impaction) via a review of the Resident Care Assessment Record
Timepoint [6] 346354 0
Baseline, 6-months post-baseline, 12 months post-baseline
Secondary outcome [7] 346355 0
Change in quality of life as measured using EQ-5D
Timepoint [7] 346355 0
Baseline, 6-months post-baseline, 12 months post-baseline
Secondary outcome [8] 346356 0
Changes in health resource use will be collected from resident care record. Data will be collected on intervention-associated resource use (pharmacist, doctor, nursing and care staff time, changes in medication and non-medication management) and resource use associated with any adverse events.
Timepoint [8] 346356 0
Baseline, 6-months post-baseline, 12 months post-baseline
Secondary outcome [9] 346434 0
Change in 24 hour movement behaviour (total activity time) as measured using GENEActiv activity tracker
Timepoint [9] 346434 0
Baseline, 6-months post-baseline, 12 months post-baseline
Secondary outcome [10] 346435 0
Change in 24 hour movement behaviour (light, moderate and vigorous intensity activity) as measured using GENEActiv activity tracker
Timepoint [10] 346435 0
Baseline, 6-months post-baseline, 12 months post-baseline

Eligibility
Key inclusion criteria
1) Receive services from an eligible aged-care facility;
2) Use four or more medicines at the time of recruitment or on more than one
medicine one of which has anticholinergic or sedative properties.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Persons with significant existing frailty burden, defined as a score of 0.40 or
above using the Frailty Index;
2) Persons with moderate or severe dementia;
3) Persons receiving palliative care;
4) Persons receiving respite care;
5) Persons participating in another research project

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will involve contacting the holder of the allocation schedule at a central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation is based on the change in frailty over 12 months and uses data from the Australian Longitudinal Study of Ageing. Assuming that the average increase in the frailty index after 12 months is 0.029 (1 deficit) and that the intervention will prevent medicine induced frailty of ½ deficit, the treatment effect is a change in the frailty index of 0.015 with a standard deviation of 0.06.
Using the function ‘ssLongFull’ from the R package ‘powerMediation’ for longitudinal sample size calculations and assuming a correlation in the frailty index over 12 months of 0.7, a sample size of 302 will provide 80% power with two-sided a=0.05 to detect a difference in the change in the frailty index over 12 months of half a deficit. If the correlation in the frailty index was 0.6 or 0.8, then a sample size of 402 and 202 would be required, respectively. For a correlation of 0.7 and a loss to follow-up of 17% based on 12 month death rates in Australian aged care residents with mild to moderate frailty, the total sample size required is 354.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/08/2018
Actual
8/08/2018
Date of last participant enrolment
Anticipated
30/06/2019
Actual
30/06/2019
Date of last data collection
Anticipated
30/06/2020
Actual
30/06/2020
Sample size
Target
354
Accrual to date
Final
275
Recruitment in Australia
Recruitment state(s)
SA,TAS

Funding & Sponsors
Funding source category [1] 298199 0
Government body
Name [1] 298199 0
Australian Government Department of Health Pharmacy Trial Program
Country [1] 298199 0
Australia
Primary sponsor type
Government body
Name
Australian Government Department of Health Pharmacy Trial Program
Address
GPO Box 9848,
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 297298 0
None
Name [1] 297298 0
Address [1] 297298 0
Country [1] 297298 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299209 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 299209 0
Ethics committee country [1] 299209 0
Australia
Date submitted for ethics approval [1] 299209 0
30/03/2017
Approval date [1] 299209 0
15/05/2017
Ethics approval number [1] 299209 0
0000036440
Ethics committee name [2] 300287 0
Tasmania Health and Medical Human Research Ethics Committee
Ethics committee address [2] 300287 0
Ethics committee country [2] 300287 0
Australia
Date submitted for ethics approval [2] 300287 0
28/11/2017
Approval date [2] 300287 0
15/02/2018
Ethics approval number [2] 300287 0
H0017022

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79662 0
Prof Libby Roughead
Address 79662 0
Quality Use of Medicines and Pharmacy Research Centre,
School of Pharmacy and Medical Sciences
University of South Australia,
Frome Road,
Adelaide SA 5001
GPO Box 2471
Country 79662 0
Australia
Phone 79662 0
+61883021238
Fax 79662 0
Email 79662 0
Libby.Roughead@unisa.edu.au
Contact person for public queries
Name 79663 0
Rebecca Bilton
Address 79663 0
Quality Use of Medicines and Pharmacy Research Centre,
School of Pharmacy and Medical Sciences
University of South Australia,
Frome Road,
Adelaide SA 5001
GPO Box 2471
Country 79663 0
Australia
Phone 79663 0
+61883022812
Fax 79663 0
Email 79663 0
rebecca.bilton@unisa.edu.au
Contact person for scientific queries
Name 79664 0
Renly Lim
Address 79664 0
Quality Use of Medicines and Pharmacy Research Centre,
School of Pharmacy and Medical Sciences
University of South Australia,
Frome Road,
Adelaide SA 5001
GPO Box 2471
Country 79664 0
Australia
Phone 79664 0
+61883022307
Fax 79664 0
Email 79664 0
renly.lim@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it. Data will be available upon request to and review by the principal investigator
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator Libby.roughead@unisa.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
379Study protocol   



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseReducing medicine-induced deterioration and adverse reactions (ReMInDAR) trial: Study protocol for a randomised controlled trial in residential aged-care facilities assessing frailty as the primary outcome.2020https://dx.doi.org/10.1136/bmjopen-2019-032851
EmbaseUsing wrist-worn accelerometers to identify the impact of medicines with anticholinergic or sedative properties on sedentary time: A 12-month prospective analysis.2023https://dx.doi.org/10.1016/j.maturitas.2023.03.006
N.B. These documents automatically identified may not have been verified by the study sponsor.