Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000751774
Ethics application status
Approved
Date submitted
17/05/2022
Date registered
25/05/2022
Date last updated
6/03/2023
Date data sharing statement initially provided
25/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
"ACTIVE-DAY": feasibility of an intervention for older adults focussing on physical activity, sedentary behaviour and sleep, from hospital to home.
Scientific title
"ACTIVE-DAY": a mixed-methods feasibility study of a coaching based intervention focussing on physical activity, sedentary behaviour and sleep behaviours in older adults during hospitalisation and following discharge home.
Secondary ID [1] 306645 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospital associated deconditioning 325569 0
Functional decline 325570 0
Physical inactivity 325571 0
Sedentary behaviour 325572 0
Condition category
Condition code
Physical Medicine / Rehabilitation 322943 322943 0 0
Physiotherapy
Public Health 322944 322944 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention we have titled "ACTIVE-DAY" combines and extends existing evidence- and behaviourally- based interventions, with the goal of helping people to sit less and move more for improved health and well-being outcomes both while in hospital and in the early period following discharge home. It consists of an inpatient phase and a home-based outpatient phase

Inpatient phase: participants will receive
- x1 face to face and one-on-one 20 minute consultation with a registered physiotherapist that works through the content of a written information handout about hospital associated deconditioning and uses a personalised coaching approach and conversation guide (https://movingmedicine.ac.uk/consultation-guides/condition/adult/hospital-associated-deconditioning/).
- up to x10 individual (one-on-one) exercise/mobility sessions (each up to 20 minutes duration) on weekdays over 2 weeks or until discharge (whichever occurs sooner). The exercise/mobility program will use a tiered and standardised program with the starting level for each session to be individually prescribed by a registered physiotherapists, and based on participants current safe mobility level. Participants completion of the exercise/mobility program will be supervised face to face by a physiotherapy assistant/student, in the hospital ward area. The goal for each session is to have provided 20 minutes of supervision within which to complete as much physical activity as possible (this time includes rest breaks). Within each session, participants should start working at the highest level aligned with their functional ability for as long as they can. Once they are no longer able to continue at that level (based on observation limits, change in perceived exertion, signs or symptoms) they should step-down a program level and then complete those activities for as long as they can, and so on until the 20-minute period is complete. The program has set end points relating to the highest and lowest level of functional ability it can cater for.
- Highest level of function is at least light intensity physical activity
- Lowest level of function is active assisted exercises in bed
The highest level has a focus on walking and physical activity, with stepped down (lower) levels based on functional (chair stand) training, followed by body-weight resistance training in a standing (hip abduction, knee flexion, bilateral heel raises, bilateral toe raises), seated (knee extension, side step/marching, knee flexion heel slides, seated heel raises, seated toe raises) or in-bed position (bridging, knee extension over fulcrum, hip abduction, heel slides, ankle pumps).
- Adherence to the inpatient phase will be recorded, with data about session dates/occurrence, reasons for non-completion, session content and any patient symptoms to be extracted from medical records.

Outpatient (home-based) phase: participants will receive x3 home visits (face to face) and x4 phone consults for delivery of a health behaviour coaching program, based on an adaptation of the i-STAND and HART programs (References: DOI: 10.1123/japa.2019-0470, DOI: 10.1016/j.cct.2021.106593). This phase will be delivered by a registered physiotherapist. Participants will receive a workbook and consumer level activity tracker (Garmin brand) device to support self-monitoring. The workbook was developed specifically for this ACTIVE-DAY study by D.Rosenberg (Kaiser Permanente for the i-STAND and HART trials, supported by grants R21AG043853 and R01HL132880) and adapted in collaboration with C.Baldwin and L.Lewis (Flinders University). The workbook authors intend to make the workbook freely available by request under a creative commons license (i.e. the workbook is not yet freely available from a public source). The workbook will be used as the guide for each coaching session (whether face to face or via phone call), such that participants are not expected to use the workbook outside of coaching sessions, but will have it continuously available as a resource to refer to at their discretion (including recording daily goal progress if desired). The program is provided individually and individualised to each participant as the program works though progressive goal setting and building new habits, integrating use of the activity tracker as one of the outward reminder strategies and inner reminders from bodily cues.
The home visits at weeks 1, 2 and 12 post discharge will be 1-1.5 hours duration, and phone calls at weeks 3, 5, 7, and 11 post discharge will be 15-30 minutes duration. The focus of each coaching session is as follows,
- Home visit week 1: 'activity profile', understanding what the last week has been like in terms of activity, sedentary, and sleep behaviours, home safety for activity check (20 minutes intervention; remaining home visit time for study outcome assessments)
- Home visit week 2: Workbook provision. Introduction (info about activity, sedentary behaviour and sleep health) and getting started (goal setting, different types of reminders, outward reminders using the activity tracker, opportunities in the home environment, action plan) (1 hour)
- Phone call week 3: moving forward (reflection on goals, inner reminders/body cues, habit reminders, action plan) (15-30 minutes)
- Phone call week 5: continuing progress (reflection on goals, dealing with setbacks, pacing, action plan) (15-30 minutes)
- Phone call week 7: rewarding yourself (reflection on goals, celebrating success, uncovering motivations, action plan) (15-30 minutes)
- Phone call week 11: thinking about others (reflection on goals, impacts of social cues and settings, action plan) (15-30 minutes)
- Home visit week 12: next steps in your journey (reflection on and setting of longer term goals using a whole of 24-day approach, revision or reminder strategies) (20 minutes intervention; remaining home visit time for study outcome assessments)
- Adherence to the outpatient phase will be recorded in session attendance logs to be maintained by the research/intervention therapist. The Garmin device is primarily being used as an intervention tool, rather than an outcome tool. Therefore while Garmin data will be available to the researchers during the intervention, it is not for the purpose of adherence tracking.
Intervention code [1] 323086 0
Rehabilitation
Intervention code [2] 323087 0
Behaviour
Intervention code [3] 323651 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330712 0
Participant experience of the program - acceptability via one-on-one, audio-recorded semi-structured interviews
Timepoint [1] 330712 0
1-week and 12-weeks post hospital discharge (primary endpoint)
Primary outcome [2] 330713 0
Feasibility metrics:
- flow of participants through the study (e.g. number of new admissions screened, number of eligible participants, number of people consented/recruited,, number of people with assessments at each outcome assessment point (from study data collection records)
Timepoint [2] 330713 0
Upon completion of the study
Primary outcome [3] 331485 0
Feasibility metrics:
- intervention fidelity (adherence) (from medical records and attendance logs)
Timepoint [3] 331485 0
12-weeks post hospital discharge
Secondary outcome [1] 407278 0
Physical activity (composite outcome): average daily time spent at different activity intensity categories (sedentary, light, moderate, vigorous intensities) measured for up to 7 days from continuous wrist worn accelerometry (Actigraph devices)
Timepoint [1] 407278 0
Baseline, 1-week post hospital discharge, 12-weeks post hospital discharge
Secondary outcome [2] 407279 0
Sedentary behaviour (composite outcome): average daily time spent in different posture categories (sitting/lying and standing and/or stepping), measured for up to up to 7 days from continuous thigh worn accelerometry (ActivPAL devices)
Timepoint [2] 407279 0
Baseline, 1-week post hospital discharge, 12-weeks post hospital discharge
Secondary outcome [3] 407280 0
Objective sleep variables (composite outcome): average nightly sleep duration, broken down to time in sleep cycles (deep, light, REM phases), measured for up to 7 days from continuous monitoring with the Withings under-mattress sensor,
Timepoint [3] 407280 0
Baseline, 1-week post hospital discharge, 12-weeks post hospital discharge
Secondary outcome [4] 407281 0
Short Performance Physical Battery (SPPB)
Timepoint [4] 407281 0
Baseline, 1-week post hospital discharge, 12-weeks post hospital discharge
Secondary outcome [5] 407282 0
Pittsburgh Sleep Quality Index
Timepoint [5] 407282 0
Baseline, 1-week post hospital discharge, 12-weeks post hospital discharge
Secondary outcome [6] 407283 0
Health related quality of life with the QOL-ACC
Timepoint [6] 407283 0
Baseline, 1-week post hospital discharge, 12-weeks post hospital discharge
Secondary outcome [7] 407284 0
Geriatric Depression Scale (15 item short form)
Timepoint [7] 407284 0
Baseline, 1-week post hospital discharge, 12-weeks post hospital discharge
Secondary outcome [8] 407285 0
Adverse events: falls (from medical records and self-report patient interview)
Timepoint [8] 407285 0
At hospital discharge, 12-weeks post hospital discharge
Secondary outcome [9] 407286 0
Length of stay (from medical records)
Timepoint [9] 407286 0
Hospital discharge
Secondary outcome [10] 407287 0
Survival and readmissions to determine Days Alive and Out of Hospital (composite outcome, from medical records)
Timepoint [10] 407287 0
- At 30-days post hospital (rehabilitation) admission, DAOH30Ad
- At 90-days post hospital (rehabilitation) admission, DAOH90Ad
- At 30-day post hospital (rehabilitation) discharge, DAOH30D/C
- At 90-days post hospital (rehabilitation) discharge DAOH90D/C
Secondary outcome [11] 409971 0
Feasibility metrics:
- secondary outcome measure completeness (from study data collection records)
Timepoint [11] 409971 0
Upon completion of the study
Secondary outcome [12] 409973 0
Sedentary behaviour: average number of daily sit to stand transitions, measured for up to up to 7 days from continuous thigh worn accelerometry (ActivPAL devices)
Timepoint [12] 409973 0
Baseline, 1-week post hospital discharge, 12-weeks post hospital discharge

Eligibility
Key inclusion criteria
- Admitted to the target inpatient rehabilitation wards
- Reason for admission relates to general rehabilitation or re-conditioning stream
- Previously living at home and were mobile prior to acute/initial admission (mobile meaning, able to complete upright ambulation, and walk 10m or more independently with or without a gait aid, was not a predominant wheelchair user and is not anticipated to be upon hospital discharge)
- Have sufficient cognition to participate in the intervention
- Able to be recruited within 3 days of admission and anticipated to need inpatient care for at least a further 3 days from the time of recruitment
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Recent (within the last month) separate hospitalisation (for more than 5 days)
- Reason for admission relates to rehabilitation for a specific neurological condition (e.g. stroke)
- Usual residence outside of the hospital catchment area
- Does not have access to someone to provide English translation for the home based part of the study
- Does not have access to a telephone at home (or ability to use independently)
- Life expectancy <6 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Aim 1: interviews will be recorded and transcribed for thematic analysis. Quantitative feasibility metrics will be reported descriptively, including a CONSORT figure.

Aim 2: outcomes will be reported descriptively at each timepoint. Change over time will be analysed by mixed effects models with physical activity, sedentary behaviour and sleep to be derived from accelerometry, but because of their multicollinearity in each 24-hour day, repeated-measures (T1, T2, T3) compositional log-ratio models will be used to assess collective change in behaviours over time. Associations between change in device-derived measures and change in clinical measures will be analysed by longitudinal isotemporal models

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/07/2022
Actual
31/08/2022
Date of last participant enrolment
Anticipated
30/03/2023
Actual
Date of last data collection
Anticipated
1/09/2023
Actual
Sample size
Target
20
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21946 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 37038 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 310970 0
Charities/Societies/Foundations
Name [1] 310970 0
Flinders Foundation
Country [1] 310970 0
Australia
Primary sponsor type
Individual
Name
Dr Claire Baldwin
Address
College of Nursing and Health Sciences
Flinders University
Flinders Drive
Bedford Park
SA, 5042
Country
Australia
Secondary sponsor category [1] 312281 0
None
Name [1] 312281 0
Address [1] 312281 0
Country [1] 312281 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310528 0
Southern Adelaide Clinical HREC
Ethics committee address [1] 310528 0
Ethics committee country [1] 310528 0
Australia
Date submitted for ethics approval [1] 310528 0
28/03/2022
Approval date [1] 310528 0
10/05/2022
Ethics approval number [1] 310528 0
2022/HRE00072

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

Contacts
Principal investigator
Name 117970 0
Dr Claire Baldwin
Address 117970 0
College of Nursing and Health Sciences
Flinders University
Flinders Drive
Bedford Park
SA, 5042
Country 117970 0
Australia
Phone 117970 0
+61 872218212
Fax 117970 0
Email 117970 0
[email protected]
Contact person for public queries
Name 117971 0
Claire Baldwin
Address 117971 0
College of Nursing and Health Sciences
Flinders University
Flinders Drive
Bedford Park
SA, 5042
Country 117971 0
Australia
Phone 117971 0
+61 872218212
Fax 117971 0
Email 117971 0
[email protected]
Contact person for scientific queries
Name 117972 0
Claire Baldwin
Address 117972 0
College of Nursing and Health Sciences
Flinders University
Flinders Drive
Bedford Park
SA, 5042
Country 117972 0
Australia
Phone 117972 0
+61 872218212
Fax 117972 0
Email 117972 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
At the conclusion of the project, we will consider and seek separate approval to make our de-identified data openly accessible through the Flinders University (institutional) hosted Repository of Open Access Datasets (ROADS). The de-identified individual participant data underlying published results is planned to consist of the specified secondary (clinical and activity behavioural) outcomes.
When will data be available (start and end dates)?
At time of publication - anticipated End 2023
Available to whom?
Open access repository, to anyone who wishes to access it
Available for what types of analyses?
Quantitative
How or where can data be obtained?
Flinders University (institutional) hosted Repository of Open Access Datasets (ROADS) https://open.flinders.edu.au/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.