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Trial registered on ANZCTR


Registration number
ACTRN12612001064897
Ethics application status
Approved
Date submitted
3/10/2012
Date registered
4/10/2012
Date last updated
27/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Lifestyle Engagement and Activity Program (LEAP) for Life project in community aged care
Scientific title
The effect of the Lifestyle Engagement and Activity Program (LEAP) for Life project on client engagement in community aged care
Secondary ID [1] 281296 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
LEAP for Life
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Geriatrics 287506 0
Dementia 287507 0
Condition category
Condition code
Public Health 287834 287834 0 0
Health service research
Neurological 287839 287839 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
LEAP for Life will train case managers or coordinators over 3 hours on incorporating individualized activities into care plans. Care workers will be trained on how to engage clients and implement individualised activities. Skills will include improved conversation and listening skills, reminiscence, humour and play, Montessori, music and planning for special events. Care workers will receive 9 hours of training in 4 sessions delivered quarterly.In addition, a “change champion” with lifestyle, occupational or diversional therapy experience, will be appointed within each site to assist case managers and care workers in preparing activities, and encourage incorporation of the newly learned skills into usual care. This change champion, will be also be available to consult with case managers on care planning, and to work a buddy shift with care workers.
Intervention code [1] 285764 0
Other interventions
Comparator / control treatment
This is a repeated measures single-arm within-subject design, across five aged care community service outlets. Clients will be assessed at 6 months pre intervention (time -6), immediately before the start of training (time 0), 6 months after commencement of the training (time 6) and 12 months after commencement of the training (time 12). All sites will receive the LEAP for Life training. The change in outcome measures from prior to treatment to the start of treatment will be utilised as a within-subjects control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288054 0
The effects of LEAP on increasing engagement of clients by care workers.

Measure 1: An engagement questionnaire developed for the study based on the Cohen-Mansfield's Observational Measure of Engagement (2009), to be completed by care workers (see below):
1)What proportion of times when you offer the client a social activity or social interaction does he/she accept?
- Almost never accepts
- Accepts about 25% of the time
- Accepts about 50% of the time
- Accepts about 75% of the time
- Accepts most of the time

2)When you are with the client, what proportion of the time are they occupied or involved with you in an activity or conversation? By occupied and involved we mean that they are participating in, or watching what is happening.
- Almost none of the time
- About 25% of the time
- About 50% of the time
- About 75% of the time
- Most of the time

3)When the client is involved with you in conversation or social activity how much attention are they paying to you or the activity?
- Not attentive
- Somewhat attentive
- Attentive
- Very attentive

4) Is the client's attitude positive or negative towards your interactions?
- Very negative
- Negative
- Somewhat negative
- Neutral
- Somewhat positive
- Positive
- Very positive

5 a) How much of the time does the client interact appropriately and meaningfully with you?
- None of the time
- A little of the time
- Some of the time
- Most or all of the time

b) How appropriate is this engagement?
- Very inappropriate
- Inappropriate
- Somewhat inappropriate
- Neutral
- Somewhat appropriate
- Appropriate
- Very appropriate

6. When the client interacts with you what proportion of the time do they actively participate by talking or physically joining in, and what proportion are they more passive and just watch or make very brief responses to questions?
- Almost always passive
- occasionally active, usually passive
- active about half the time,
- passive about half the time
- usually active, occasionally passive
- almost always active


Measure 2: A researcher rated questionnaire developed for the study on amount of engagement based on interviews with the client and family. The researcher will ask questions such as:
-What do you talk about with the care workers during their visits?
-When the care worker is doing the housework what do you do? Do you join in or talk to them while they are cleaning?
-When the care worker is looking after your personal care, do you talk together?
-When the care worker takes you out, do you talk together? What do you talk about?
-Do you sometimes do something social or recreational together such as have a cup of tea or go for a walk?
When you and your care worker spend time talking together, how much do you enjoy this?
-When you and your care worker spend time doing things together, how much do you enjoy this?
-How much do you value the company of your care workers? Do you look forward to their company?
-Do you feel like the care workers take an interest in you and your life? Do they ask you about yourself?
-How would you describe your care workers?
-How well do you get on with your care workers? Do you think of your care workers as friends?
-How do you feel after your care workers visits? Do you feel pretty happy, a bit annoyed, or no different really?
-Does time pass quicker when your care workers are around?

Based on this interview, the researcher will rate the following questions on a Likert scale 1-5:
1.Rate the amount of social conversation that client /family report experiencing
2.Rate the amount of recreational activities that client/family report experiencing?
3.Based on both client/family report, rate how the client seems to feel about any social conversation with their care workers
4.Based on both client/family report, rate how the client seems to feel about any recreational activities with their care workers
Timepoint [1] 288054 0
Both measures at all timepoints: at 6 months pre training (time -6), immediately before the start of training (time 0), 6 months after commencement of the training (time 6) and 12 months after commencement of the training (time 12).
Secondary outcome [1] 299343 0
The effects of LEAP on client satisfaction with care.

Assessed by the Homecare satisfaction measure - care worker and case manager subscales (Geron SM, Smith K, Tennstedt S, et al. The Home Care Satisfaction Measure. The Journals of Gerontology Series B: Psychological Sciences and Social Sciences. 2000; 55: S259-S70).
Timepoint [1] 299343 0
At all timepoints: at 6 months pre training (time -6), immediately before the start of training (time 0), 6 months after commencement of the training (time 6) and 12 months after commencement of the training (time 12).
Secondary outcome [2] 299344 0
The effects of LEAP on client dysphoria/depression, for clients rated as depressed at baseline.

Measure 1: Geriatric Depression Scale ( J A Yesavage Geriatric Depression Scale Psychopharmacology Bulletin (1988) 24:4;709-711)

Measure 2: Dysphoria subscale of the Neuropsychiatric Inventory (de Medeiros et al. (2010). International Psychogeriatrics. 22(6): 984-994.)
Timepoint [2] 299344 0
All measures at all timepoints: at 6 months pre training (time -6), immediately before the start of training (time 0), 6 months after commencement of the training (time 6) and 12 months after commencement of the training (time 12).
Secondary outcome [3] 299345 0
The effect of LEAP on client loneliness, on clients assessed as lonely at baseline

Assessed by UCLA Loneliness Scale (Russell D, Peplau LA, Cutrona CE. The Revised UCLA Loneliness Scale: Concurrent and Discriminant Validity Evidence. J Pers Soc Psychol. 1980; 39: 472-80)
Timepoint [3] 299345 0
At all timepoints: at 6 months pre training (time -6), immediately before the start of training (time 0), 6 months after commencement of the training (time 6) and 12 months after commencement of the training (time 12).
Secondary outcome [4] 299346 0
The effect of LEAP on client agitation, on clients assessed as agitated at baseline

Measure 1: Agitation subscale of the Neuropsychiatric Inventory (de Medeiros et al. (2010). International Psychogeriatrics. 22(6): 984-994.)

Measure 2: Cohen-Mansfield Agitation Inventory - Relative (Cohen-Mansfield J. A description of agitation in a nursing home. J Gerontol. 1989; 44: M77-84)
Timepoint [4] 299346 0
All measures at all timepoints: at 6 months pre training (time -6), immediately before the start of training (time 0), 6 months after commencement of the training (time 6) and 12 months after commencement of the training (time 12).
Secondary outcome [5] 299347 0
The effect of LEAP on client apathy on clients assessed as apathetic at baseline

Measure 1: Apathy subscale of the Neuropsychiatric Inventory (de Medeiros et al. (2010). International Psychogeriatrics. 22(6): 984-994.)

Measure 2: Apathy Evaluation Scale - self and proxy versions (RS Marin, RC Biedrzycki, S Firinciogullari: Reliability and Validity of the Apathy Evaluation Scale, Psychiatry Research, 38:143-162, 1991).
Timepoint [5] 299347 0
All measures at all timepoints: at 6 months pre training (time -6), immediately before the start of training (time 0), 6 months after commencement of the training (time 6) and 12 months after commencement of the training (time 12).

Eligibility
Key inclusion criteria
- Clients receiving services from the five partner sites in New South Wales (Baptist Community Services - Liverpool; Baptist Community Services - Central Coast; Australian Nursing Home Foundation; Multicultural Community Care Service; and the Whiddon Group - Glenfield.
- Clients receiving community aged care packages: CACP, EACH or EACH-D.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clients will be ineligible if they are;
- foreshadowed to stop accessing the service,
- acutely unwell,
- under public guardianship with no person responsible to consent on their behalf.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
268
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5784 0
2178
Recruitment postcode(s) [2] 5785 0
2171
Recruitment postcode(s) [3] 5786 0
2170
Recruitment postcode(s) [4] 5787 0
2168
Recruitment postcode(s) [5] 5788 0
2162
Recruitment postcode(s) [6] 5789 0
2176
Recruitment postcode(s) [7] 5790 0
2256
Recruitment postcode(s) [8] 5791 0
2257
Recruitment postcode(s) [9] 5792 0
2250
Recruitment postcode(s) [10] 5793 0
2251
Recruitment postcode(s) [11] 5794 0
2165
Recruitment postcode(s) [12] 5795 0
2166
Recruitment postcode(s) [13] 5796 0
2136
Recruitment postcode(s) [14] 5797 0
2134
Recruitment postcode(s) [15] 5798 0
2194
Recruitment postcode(s) [16] 5799 0
2200
Recruitment postcode(s) [17] 5800 0
2007
Recruitment postcode(s) [18] 5801 0
2194
Recruitment postcode(s) [19] 5802 0
2167

Funding & Sponsors
Funding source category [1] 286060 0
Government body
Name [1] 286060 0
Encouraging Better Practice for Aged care (EBPAC), Department of Health and Ageing
Country [1] 286060 0
Australia
Primary sponsor type
University
Name
Dementia Collaborative Research Centre, University of New South Wales
Address
FAO: Dr. Lee-Fay Low,
Room 302, Level 3
AGSM Building (G27)
The University of New South Wales
UNSW SYDNEY NSW 2052
Country
Australia
Secondary sponsor category [1] 284872 0
None
Name [1] 284872 0
Address [1] 284872 0
Country [1] 284872 0
Other collaborator category [1] 277092 0
University
Name [1] 277092 0
University of Sydney
Address [1] 277092 0
FAO: Associate Professor Yun-Hee Jeon,
Sydney Nursing School, Room A5.13, MO2, 88 Mallett Street, Camperdown, NSW, 2050
Country [1] 277092 0
Australia
Other collaborator category [2] 277093 0
Charities/Societies/Foundations
Name [2] 277093 0
Arts Health Institute
Address [2] 277093 0
FAO: Dr. Maggie Haertsch,
Arts Health Institute, PO Box 1772, Newcastle, NSW, 2300.
Country [2] 277093 0
Australia
Other collaborator category [3] 277094 0
Other Collaborative groups
Name [3] 277094 0
Centre for Applied Research in Dementia
Address [3] 277094 0
FAO Dr. Cameron Camp,
34208 Aurora Road, #182 Solon, OH 44139.
Country [3] 277094 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288110 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 288110 0
UNSW Grants Management Office
Rupert Myers Building, Level 3 (M15)

The University of New South Wales NSW 2052
Ethics committee country [1] 288110 0
Australia
Date submitted for ethics approval [1] 288110 0
Approval date [1] 288110 0
31/07/2012
Ethics approval number [1] 288110 0
HC12383

Summary
Brief summary
LEAP for Life is a training package for packaged community care staff which aims to improve engagement of clients by providing more individualised conversation and activities. This single arm trial will follow staff and their clients for 18 months, 6 months before the training begins, and across 12 months of training. Staff will be trained on how to incorporate engagement strategies and activities into care plans, and how to deliver these strategies and activities into practice. They will be supported by a change champion over 12 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34754 0
Dr Lee-Fay Low
Address 34754 0
Dementia Collaborative Research Centre, Room 303, Level 3 AGSM Building, University of New South Wales, Sydney, NSW, 2052
Country 34754 0
Australia
Phone 34754 0
+61 (0) 2 9385 2599
Fax 34754 0
Email 34754 0
[email protected]
Contact person for public queries
Name 18001 0
Dr. Jess Baker
Address 18001 0
Dementia Collaborative Research Centre
Room 304, Level 3 AGSM Building
University of New South Wales,
Sydney, NSW, 2052
Country 18001 0
Australia
Phone 18001 0
+61 (0) 2 9385 2605
Fax 18001 0
Fax: + 61 (0)2 93852299
Email 18001 0
[email protected]
Contact person for scientific queries
Name 8929 0
Dr. Jess Baker
Address 8929 0
Dementia Collaborative Research Centre
Room 304, Level 3 AGSM Building
University of New South Wales,
Sydney, NSW, 2052
Country 8929 0
Australia
Phone 8929 0
+61 (0) 2 9385 2605
Fax 8929 0
Fax: + 61 (0)2 93852299
Email 8929 0
[email protected]

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