Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001186347
Ethics application status
Approved
Date submitted
1/08/2017
Date registered
11/08/2017
Date last updated
4/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of health coaching with accelerometer feedback on physical inactivity in older people at risk of falls
Scientific title
A randomized controlled feasibility study to evaluate the effects of a goal-setting coaching intervention using feedback from accelerometer on sedentary time in older people at risk of falls
Secondary ID [1] 292438 0
None
Universal Trial Number (UTN)
Trial acronym
SMART-MOVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 304046 0
Sedentary 304047 0
Condition category
Condition code
Physical Medicine / Rehabilitation 303372 303372 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 303647 303647 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SMART-MOVE
Specific, Measurable, Attainable, Relevant and Time-bound (SMART) Goal-setting coaching and technology support to reduce older people’s sedentary time (MOVE)
1.. Materials - Participants will receive:
• The ‘Choose Health: Be Active’ booklet developed by the Australian Government in collaboration with Department of Veterans’ Affairs and Department of Health and Aging to help older Australians achieve sufficient physical activity for good health as they age.
• An accelerometer to record physical activity for a week (at week 1, 12 and 24).
• A pedometer to record daily step counts to be worn for first 12 weeks during waking hours.
• A SMART goal-setting booklet to document their goals to reduce sedentary behaviour and daily step counts as per pedometer
2. Procedures
Face-to-face coaching with goal setting will occur after accelerometer reading is available at the start of the study. A second face-to-face coaching will occur at week 6. The approximate duration of the coaching session will be 1 hour and 30 min for the first and 30-45 min for the second. Telephone interviews will occur fortnightly on four occasions (week 2, 4, 8, and 10) to identify barriers and assist participants to achieve their physical activity goals. Telephone interviews will be approximately 15 minutes.
3. Who provide the health coaching
A medical practitioner will deliver the face-to-face coaching and telephone interview interventions
4. How
The intervention will be tailored to suit the participant daily activities. SMART (specific, measurable, attainable, relevant, time-bound) goals will be set. At the first face-to-face meeting, participants will set three goals to reduce sedentary behavior. One goal will be incrementally introduced every 2 weeks so that by week 6, the participant will be working on three goals. At the second face-to-face meeting at week 6, the participant will set another three goals that will be added incrementally every fortnight.
Participants in the intervention arm will be provided with information about their duration of time spent upright (accelerometer) and total number of steps (pedometer) taken each day.
Goals are set to increase their time spent upright and total number of steps taken. Participations will calculate the mean daily steps using the pedometer over 7 days and increase by 200 steps from the mean per week as a goal. They will also be encouraged to attend falls prevention classes if they have not participated in one in the preceding 12 months.
5. Where
The intervention will be delivered to community dwelling older people who had falls in the last 12 months or are at risk of one. This coaching sessions will occur in the study centre.
6. When and how much
Following baseline assessment, an accelerometer will be worn for one week. After one week, participants will return for a face-to-face coaching where goal setting will occur. This will last approximately 1 hour and 30 min. Participants will be given a pedometer (FitBit) which will be worn on the waist on a daily basis during waking time for the first 12 weeks. Participants will be provided a diary to record their daily step counts. At week 6, a second face-to-face coaching will be conducted where goals will be reviewed and additional goals set (30-45 min in duration). Phone interviews will occur for up to 15 minutes fortnightly on week 2, 4, 8, 10. Participants will wear the accelerometer at week 12 for one week. After one week, they will return for a final assessment. No intervention will be conducted from week 13 to week 24. At week 24, participants will be required to wear the accelerometer again for 1 week and assessed at the end of 1 week for retention of the intervention.
Intervention adherence will be assessed by participants' self-reporting and interviews (face-to-face and telephone) with researchers. Participants will be provided with a diary to record their daily pedometer step counts and steps taken to achieve their target to reduce sedentary behaviour. Diary will be checked at week 6 and week 12. Phone interviews will also be used to assess intervention adherence.
7. Tailoring
The recommended physical activity plan will be tailored to individual needs based on participants’ goals, baseline levels, preferences and physical ability.
Intervention code [1] 298616 0
Behaviour
Intervention code [2] 298831 0
Lifestyle
Comparator / control treatment
The control group will only receive the written information about the benefits of being active (i.e. the Choose Health: Be Active booklet) and will be provided with their accelerometer data readings only during the 1st face-to-face meeting. They will attend another face-to-face session at week 6 to evaluate for progress. Like the intervention group, they will be provided with information about what participant should do in the event of a fall. They will also be encouraged to join a falls prevention class if they have not participated in one in the last 12 months.
Control group
Active

Outcomes
Primary outcome [1] 302761 0
Feasibility of intervention
Feasibility indicators include trial process (recruitment, retention, acceptability, adherence and safety) to interventions. Adherence to the intervention will be assessed using accelerometry data, pedometer, participant diary and goal attainment scaling. Acceptability of the intervention will be assessed with a questionnaire designed specifically for this study. Safety will be assessed by participant notifying the researchers of any major adverse events include fall, fracture or hospitalization.
Timepoint [1] 302761 0
12 weeks
Primary outcome [2] 303008 0
Total sedentary time - Duration of sedentary time in the previous week, as assessed by accelerometer
Timepoint [2] 303008 0
12 weeks
Primary outcome [3] 303010 0
Total sedentary time - Duration of sedentary time in the previous week, as assessed by accelerometer
Timepoint [3] 303010 0
24 weeks
Secondary outcome [1] 336930 0
Number of falls in the previous 12 and 24 weeks based on participants' self-reporting
Timepoint [1] 336930 0
12 and 24 weeks
Secondary outcome [2] 336931 0
Duration of self-reported sedentary time in the week of prior to completing the questionnaire according to the Measure of Older Adults' Sedentary Time (MOST) questionnaire
Timepoint [2] 336931 0
12 and 24 weeks
Secondary outcome [3] 337684 0
Falls efficacy scale to assess fear of falling
Timepoint [3] 337684 0
12 and 24 weeks
Secondary outcome [4] 337685 0
Change in gait speed based on six-metre walk test
Timepoint [4] 337685 0
12 and 24 weeks

Eligibility
Key inclusion criteria
(1) Aged 65 years and above
(2) screen falls risk positive (scores 4 or higher on the STEADI falls risk self assessment tool) ;
(3) community-dwelling;
(4)rapid cognitive screen of 6
(5) able to walk independently up to 10 m with or without walking aid;
(6) able to converse in English; and
(7) score of 1 or more on FRAIL screen.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) unable to participate in proposed intervention;
(2) terminal phase of illness;
(3) plans to move out of the metropolitan area within 6 months of the screening clinic visit;
(4) plans to be away for more than 2 consecutive weeks during the study intervention period; and
(5) currently participating in another similar physical activity interventional study or program.

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)
Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
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
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive analyses will be conducted using mean with standard deviation, median with interquartile range and frequency for baseline characteristics. These characteristics include age, gender, ethnicity, physical function, health status, quality of life and mental status. Mean group differences will be examined using independent samples t test for normally distributed data and nonparametric tests (Kruskal-Wallis and Mann-Whitney U) for non-normally distributed data. Differences in frequency of variables will be compared using chi-square test.
Analysis of variance (ANOVA) will be used to test the post-intervention difference at 12 and 24 weeks between the two groups. The covariates in the analysis will include baseline values of the dependent variable and any variable significantly different between groups at baseline. Group mean values for adherence variable at 12 and 24 weeks (retention rate, days the accelerometer and pedometer was worn) will be analyzed by an independent t test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/08/2017
Actual
2/10/2017
Date of last participant enrolment
Anticipated
1/10/2018
Actual
Date of last data collection
Anticipated
1/04/2019
Actual
Sample size
Target
80
Accrual to date
70
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 8541 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 16638 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 296998 0
University
Name [1] 296998 0
Adelaide Geriatric Research and Training with Aged Care (G-TRAC) with University of Adelaide
Country [1] 296998 0
Australia
Funding source category [2] 297205 0
Charities/Societies/Foundations
Name [2] 297205 0
Resthaven Incorporated
Country [2] 297205 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital
Address
25 Woodville Road, Woodville South, SA 5011
Country
Australia
Secondary sponsor category [1] 296213 0
None
Name [1] 296213 0
Address [1] 296213 0
Country [1] 296213 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298195 0
The Queen Elizabeth Hospital Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [1] 298195 0
Basil Hetzel Institute
28 Woodville Road
Woodville South SA 5011
Ethics committee country [1] 298195 0
Australia
Date submitted for ethics approval [1] 298195 0
20/03/2017
Approval date [1] 298195 0
06/06/2017
Ethics approval number [1] 298195 0
HREC/17/TQEH/58

Summary
Brief summary
One in three older people fall at least once a year and sedentary behaviour (more than 10 hours of inactivity during waking hours) is a risk factor. These dual problems need to be addressed effectively as the ageing population increases. This study is a prospective single-blinded randomized controlled trial (RCT) with a follow-up period of 6 months. This trial aims to establish the feasibility of an individualised goal-setting coaching intervention using feedback from an accelerometer on sedentary time in older people with a recent fall or at risk of one compared to a health advice brochure over 24 weeks. Forty community-dwelling older adults will be randomised to the intervention group and control group respectively. Primary outcomes include feasibility of the intervention and change in sedentary time measured at 12 and 24 weeks after randomisation. Secondary outcomes include falls, fear of falling and walking speed. This trial will address a key gap to evaluate an intervention that could be implemented within the primary health care settings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76290 0
Dr Kareeann Khow
Address 76290 0
Adelaide G-TRAC Centre
61 Silkes Road, Paradise SA 5075
Country 76290 0
Australia
Phone 76290 0
+61883132144
Fax 76290 0
Email 76290 0
kareeann.khow@adelaide.edu.au
Contact person for public queries
Name 76291 0
Dr Kareeann Khow
Address 76291 0
Adelaide G-TRAC Centre
61 Silkes Road, Paradise SA 5075
Country 76291 0
Australia
Phone 76291 0
+61883132144
Fax 76291 0
Email 76291 0
kareeann.khow@adelaide.edu.au
Contact person for scientific queries
Name 76292 0
Dr Kareeann Khow
Address 76292 0
Adelaide G-TRAC Centre
61 Silkes Road, Paradise SA 5075
Country 76292 0
Australia
Phone 76292 0
+61883132144
Fax 76292 0
Email 76292 0
kareeann.khow@adelaide.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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