Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000109404
Ethics application status
Approved
Date submitted
22/01/2016
Date registered
2/02/2016
Date last updated
9/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of occupational therapy and activity pacing with older adults who are inpatients at a rehabilitation hospital.
Scientific title
A randomised controlled trial of occupational therapy and activity pacing with deconditioned older adults in sub-acute care.
Secondary ID [1] 288322 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hospital associated deconditioning 297288 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297483 297483 0 0
Occupational therapy
Musculoskeletal 297620 297620 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Activity pacing has been defined as the regulation of activity. For the purpose of this research, activity pacing will be operationalized as seven activity pacing techniques which include -
1. Use self-monitoring to listening to your body
2. Use short regular rests during the day and during activities
3. Find a sustainable baseline and then gradually increase activity
4. Break tasks into manageable parts
5. Plan tasks and set goals
6. Alternate high energy tasks with low energy tasks
7. Prioritise tasks and delegate where able
Occupational therapy with activity pacing will include-
a. An occupational performance review and the establishment of occupational performance goals-involves the standard occupational therapy initial assessment where a patient’s past and current occupational performance (personal, domestic and community) is reviewed and goals are determined to enable the patient to return to their home environment and participate in their previous lifestyle (30 mins at admission to the hospital)
b. Occupational therapy interventions to achieve goals as directed by the treating occupational therapist- will be variable depending on the goals of the patient but could include occupational therapy assessment and interventions (facilitating the occupation/person/environment balance, education, service provision, equipment prescription) in the areas of personal care, domestic tasks (meal preparation, housework, gardening, laundry etc.), community tasks (shopping, leisure, banking, etc.), work, driving and a home assessment. (Variable session length depending on goals set-4-7 hours, across the whole length of stay which could be 10-14 days)
c. An initial individual education session about activity pacing and how this technique can be used to improve participation in daily occupations. The session will be conducted using a standard iPad presentation and the content of the session will include what is deconditioning, what is a reconditioning program, what is activity pacing is and the activity pacing technique. The patient will be given an activity pacing education booklet and orientated to the information in the booklet. The booklet is for the patient to keep and read in their own time (30 mins, second day after admission)
d. Five group sessions with the aim of building the level of participation, confidence and independence in occupation through the use of the activity pacing techniques in everyday tasks. Four sessions will be activity based and each day will focus on different activity pacing technique as follows:
Day One-Use self-monitoring to listening to your body
Day Two-Break tasks into manageable parts and use short regular rests during the day and during activities
Day Three-Find a sustainable baseline and then gradually increase activity and plan tasks and set goals
Day Four-Prioritise tasks and delegate where able and alternate high energy tasks with low energy tasks
One of the group sessions will be conducted as a group education session where the activity pacing techniques are reinforced. The use of the activity pacing techniques will be generally applied to different occupations. The education will refer to the booklet that was given in the individual activity pacing education session. The group education session will follow a structured format (power point presentation) and will encourage group discussion and problem solving about independence in daily occupations (5 hours over 5 days, three or four days after admission)
e. A final individual session reviewing the activity pacing intervention and how this applies to the patients usual daily occupations in hospital and in their home environment. Occupation based handouts are used to reinforce the use of the activity pacing techniques in occupations post discharge. Individualised agreed instructions for use of the activity pacing techniques will be written on these handouts. (30 mins, day before discharge)
Total number of OT sessions: between 12-15 times
Resources: patients will be provided with an Activity Pacing booklet and occupation based Activity Pacing handouts related to tasks done in their own environment
Adherence will be recorded attendance at each of the above sessions
Intervention code [1] 293623 0
Rehabilitation
Comparator / control treatment
Activity pacing has been defined as the regulation of activity. For the purpose of this research, activity pacing will be operationalized as seven activity pacing techniques which include -
1. Use self-monitoring to listening to your body
2. Use short regular rests during the day and during activities
3. Find a sustainable baseline and then gradually increase activity
4. Break tasks into manageable parts
5. Plan tasks and set goals
6. Alternate high energy tasks with low energy tasks
7. Prioritise tasks and delegate where able
Occupational therapy with no activity pacing will include-
a. An occupational performance review and the establishment of occupational performance goals-involves the standard occupational therapy initial assessment where a patient’s past and current occupational performance (personal, domestic and community) is reviewed and goals are determined to enable the patient to return to their home environment and participate in their previous lifestyle (30 mins at admission to the hospital)
b. Occupational therapy interventions to achieve goals as directed by the treating occupational therapist- will be variable depending on the goals of the patient but could include occupational therapy assessment and interventions (facilitating the occupation/person/environment balance, education, service provision, equipment prescription) in the areas of personal care, domestic tasks (meal preparation, housework, gardening, laundry etc.), community tasks (shopping, leisure, banking, etc.), work, driving and a home assessment. (Variable session length depending on goals set-4-7 hours, across the whole length of stay which could be 10-14 days)

To ensure this group is not disadvantaged, patients will receive 2 education sessions on the same day after outcome measures have been completed 2 days prior to discharge-
a. Activity Pacing Education- The session will be conducted 1:1 using a standard iPad presentation and the content of the session will include what is deconditioning, what is activity pacing and the activity pacing techniques. The patient will be given an activity pacing education booklet and orientated to the information. The session will be personalised to the participant’s own occupations and environment. Occupation based handouts will be used to reinforce the use of the activity pacing techniques in occupations post discharge. Individualised agreed instructions for use of the activity pacing techniques will be written on these handouts (30 mins two days prior to discharge)
b. Activity Pacing Education- The patient will be given the opportunity to practice the activity pacing techniques in meaningful tasks and the use of the activity pacing techniques in occupations post discharge will be reinforced (30 mins two days prior to discharge)
Total number of OT sessions: between 7-10 times
Resources: patients will be provided with an Activity Pacing booklet and occupation based Activity Pacing handouts related to tasks done in their own environment
Adherence will be recorded attendance at each of the above sessions
Control group
Active

Outcomes
Primary outcome [1] 297050 0
Participation in occupation assessed by the Australian Therapy Outcome Measures-Occupational Therapy (AusTOMs-OT).
Timepoint [1] 297050 0
Two days prior to discharge and three months post discharge from rehabilitation hospital
Primary outcome [2] 297051 0
Quality of life assessed by the Short Form-36 Health Survey (SF-36)
Timepoint [2] 297051 0
Two days prior to discharge and three months post discharge from rehabilitation hospital
Primary outcome [3] 297052 0
Self-efficacy in daily tasks assessed by the Self-Efficacy Gauge (SEG)
Timepoint [3] 297052 0
Two days prior to discharge and three months post discharge from rehabilitation hospital
Secondary outcome [1] 319918 0
Fatigue assessed by the Short Form-36 Health Survey (SF-36)
Timepoint [1] 319918 0
Two days prior to discharge and three months post discharge from rehabilitation hospital
Secondary outcome [2] 319919 0
Pain assessed by the Short Form-36 Health Survey (SF-36)
Timepoint [2] 319919 0
Two days prior to discharge and three months post discharge from rehabilitation hospital
Secondary outcome [3] 319920 0
Self-efficacy with Activity Pacing techniques assessed by the Activity Pacing Assessment designed specifically for this study
Timepoint [3] 319920 0
Two days prior to discharge and three months post discharge from rehabilitation hospital

Eligibility
Key inclusion criteria
Older than 65 years, English as a first language and a score of 24 or more on the Mini-Mental State Examination (MMSE). Potential participants will also need to have been living independently in the community with or without supports prior to their acute admission.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant cognitive, language, hearing, visual or behavioural issues that would require the intervention to be individually tailored to their needs, if they have previously been admitted for a reconditioning program at DRH or another hospital, if they are discharged to convalescence care (interim) and not directly to home, if they are discharged to a nursing home or if they have a comorbidity that may also impact on symptoms of fatigue and pain (active treatment of cancer, chronic disease, neurological conditions, cardio-pulmonary problems, chronic pain).

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size calculation was completed based on an effect size d=0.8 with an a probability of 0.05 using a 90% power ratio (beta=0.1). This estimated that 34 participants would be required in each of the groups. To accommodate withdrawal and lost to follow up numbers a sample size has been set at 100, that is 50 participants in each group.
All participants’ data will be analysed according to group allocation using an intention to treat approach. Statistical analysis will be completed using SPSS software (version 22). Differences between the base line characteristics of the two groups will be assessed using a t-test for continuous data and a chi squared for categorical data. Missing data will be dealt with using a method of last observation carried forward (LOCF).
Primary Analysis
1. Is there bias?
- use a histogram to check if the data and variance are normally distributed
- test for skewness and kurtosis of data and convert these scores to z scores to evaluate their significance (greater than 1.96 then significant)
-use scatterplots to check linear model and check for outliers
-check for heterogeneity of data using Levene’s test
-reduced bias by transforming the data appropriately
2. Is there a difference in the two groups on each of the outcome measures?
-calculate means and standard deviations for each of the outcome measure results for the two groups at each time interval
-calculate a standard error with 95% confidence intervals
-conduct a two-way ANOVA for OT with AP and OT without AP and difference in change scores for participation in occupation, quality of life/health status, self-efficacy for use of activity pacing techniques, self-efficacy in general, fatigue and pain
3. Does age, gender, comorbidities influence the outcome?
-conduct moderation and mediation analysis to determine the interaction effects of age, gender and level of comorbidities

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2016
Actual
Date of last participant enrolment
Anticipated
31/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5044 0
Donvale Rehabilitation Hospital - Donvale
Recruitment postcode(s) [1] 12531 0
3111 - Donvale

Funding & Sponsors
Funding source category [1] 292746 0
Self funded/Unfunded
Name [1] 292746 0
Amanda Timmer
Country [1] 292746 0
Australia
Primary sponsor type
Individual
Name
Amanda Timmer
Address
Donvale Rehabilitation Hospital
1119 Doncaster Road
Donvale VIC 3111
Country
Australia
Secondary sponsor category [1] 291415 0
None
Name [1] 291415 0
Address [1] 291415 0
Country [1] 291415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294229 0
Central Queensland University Human Research Ethics Committee
Ethics committee address [1] 294229 0
Central Queensland University
Office of Research Services
Bruce Highway
Building 32
Rockhampton QLD 4702
Ethics committee country [1] 294229 0
Australia
Date submitted for ethics approval [1] 294229 0
15/03/2016
Approval date [1] 294229 0
12/05/2016
Ethics approval number [1] 294229 0
H16/03-045

Summary
Brief summary
Activity pacing is an occupational therapy rehabilitation intervention commonly used with older adults who have deconditioned during an acute hospital admission. Activity pacing involves teaching people different techniques to regulate their level of activity and how they do their daily tasks. Activity pacing and energy conservation have been shown to have some effect with persistent pain populations and in people with chronic disease. Yet there is currently no evidence for use with the deconditioned older adult. For the purpose of this research, activity pacing will include seven activity pacing techniques -
1. Use self-monitoring to listening to your body
2. Use short regular rests during the day and during activities
3. Find a sustainable baseline and then gradually increase activity
4. Break tasks into manageable parts
5. Plan tasks and set goals
6. Alternate high energy tasks with low energy tasks
7. Prioritise tasks and delegate where able
The aim of this study will be to evaluate the effectiveness of activity pacing with deconditioned older adults on their participation in everyday tasks. This will be done by comparing two groups- 1) occupational therapy rehabilitation with activity pacing, 2) occupational therapy rehabilitation with no activity pacing. A secondary aim will be to compare the effects of the two interventions on quality of life and well-being, knowledge of activity pacing techniques and symptom management (pain, fatigue and self-efficacy).
Deconditioned older adults who are admitted to a private hospital from the acute setting will be invited to participate. A randomised controlled method will be used to compare the effectiveness of occupational therapy rehabilitation with activity pacing and occupational therapy rehabilitation with no activity pacing. The activity pacing intervention will be multi-faceted with individual sessions, group education, written handouts and a practical group allowing practice of the above activity pacing techniques. To ensure the second group (occupational therapy with no activity pacing) are not disadvantaged, patients will receive modified activity pacing education (two individual sessions- one education and one practical, written handouts) 2 days prior to discharge and after the completion of outcome measures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62750 0
Mrs Amanda Timmer
Address 62750 0
Donvale Rehabilitation Hospital
1119 Doncaster Road,
Donvale VIC 3111
Country 62750 0
Australia
Phone 62750 0
+61 3 98411484
Fax 62750 0
Email 62750 0
[email protected]
Contact person for public queries
Name 62751 0
Mrs Amanda Timmer
Address 62751 0
Donvale Rehabilitation Hospital
1119 Doncaster Road
Donvale VIC 3111
Country 62751 0
Australia
Phone 62751 0
+61 3 98411484
Fax 62751 0
Email 62751 0
[email protected]
Contact person for scientific queries
Name 62752 0
Mrs Amanda Timmer
Address 62752 0
Donvale Rehabilitation Hospital
1119 Doncaster Road
Donvale VIC 3111
Country 62752 0
Australia
Phone 62752 0
+61 3 98411484
Fax 62752 0
Email 62752 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseOccupational therapy and activity pacing with hospital-associated deconditioned older adults: a randomised controlled trial.2020https://dx.doi.org/10.1080/09638288.2018.1535630
N.B. These documents automatically identified may not have been verified by the study sponsor.