Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000347369
Ethics application status
Approved
Date submitted
13/02/2017
Date registered
7/03/2017
Date last updated
11/01/2019
Date data sharing statement initially provided
11/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
HOMeCare: Caring for the Dementia Caregiver and their Loved One via the HOMeCare Exercise and Mindfulness for Health Program
Scientific title
HOMeCare: Caring for the Dementia Caregiver and their Loved One via the HOMeCare Exercise and Mindfulness for Health Program to Improve Functional Capacity and Wellbeing
Secondary ID [1] 291169 0
None
Universal Trial Number (UTN)
Trial acronym
HOMeCare
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 302038 0
Caregiver burden 302039 0
Condition category
Condition code
Public Health 301673 301673 0 0
Health promotion/education
Physical Medicine / Rehabilitation 301675 301675 0 0
Other physical medicine / rehabilitation
Neurological 301696 301696 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dyads will be randomised after baseline assessment, stratified by level of SPPB (<8; 8-10) by an offsite statistician and concealed until allocation by interventionist. The experimental program consists of an adaptation of an 8-wk Mindfulness Training Program for the caregiver followed by a 8-wk home-based balance and strength training program for the participant with dementia, during which time the Mindfulness practice will continue to be reinforced and monitored.

All experimental dyads will have a home visit by the interventionist after the baseline assessment is complete, at which time they will receive an iPad, and detailed in-person instruction in use of the iPad for viewing the instructional materials, downloading videos and written materials, and Face Time videoconferencing. The materials will all be accessible via a single HOMeCARE website which has been purpose-built for this study, with the needs of the older adults caregiver specifically in mind. All software and hardware and Internet data packages needed for the delivery and monitoring of the intervention components will be supplied to the participants at no cost for the duration of the trial.

Mindfulness Training for the Caregiver:
The Mindfulness training course will utilise the internet-based Palouse Mindfulness Based Stress Reduction (MBSR) course materials and home practice program. This online MBSR training course has been modelled on the program founded by Jon Kabat-Zinn in 1979 at the University of Massachusetts Medical School. The 8-week program comprises of recorded video lectures on the topic of Mindfulness, practice tips, guided audio recordings for daily practice, and publications on mindfulness including media coverage. We encourage participants to allocate between 30 minutes – 1 hour daily session for formal mindfulness practice.

Throughout the mindfulness program, participants are encouraged to log in their experiences. Formal practice forms are used to record their feelings during the guided practice sessions, while informal practice forms are used to reflect and record how mindfulness was applied during their daily activities. Caregivers will be asked to log their daily Mindfulness practice into the HOMeCARE website on their iPads, and these logs will be set for automatic uploading to the study interventionist so that adoption and adherence are optimized and relapse prevented

Due to the specific and significant stressors imposed by dementia caregiving, the basic Palouse course will be supplemented by targeted materials developed for the unique stresses experienced by dementia caregivers by the investigators of this project. The supplementary materials form the additional 4-week mindfulness program for the caregiver which runs concurrently with the 8-week exercise program.

The supplemented materials are sourced from the Palouse website and comprises of optional reading materials outside the formal 8-week program. Additional materials were sourced from dementia care and caregiver organizations with their consent. These include resources from the Presence Care Project and the Aged Care Channel (ACC). Resources included media publications, reflections, video interviews, and caregiving tips for dementia. All materials will be delivered through the dedicated HOMeCARE website on their iPads.
We will augment the internet course with Face Time interaction with a trained Palouse Mindfulness Based Stress Reduction (MBSR) facilitator on a weekly basis during the full study period. Estimated duration of the face time sessions will be set to one hour however this may vary on a case by case basis. The session includes an opportunity for the caregiver to discuss the person with dementia’s progress with the exercise once commenced, tips on coaching and training the person with dementia, the caregiver’s own progress with the mindfulness materials, and an opportunity to report any adverse events during the week. The facetime session will also allow the interventionist to modify exercise programs for the person with dementia as appropriate.

Exercise program for the person with Dementia:
The study investigators will be training the caregivers to deliver the HOMeCARE exercise program to their loved ones once they have finished 4 weeks of their 8-week Mindfulness course. Free weights and resistance bands will be provided as well as online pictures and instructional booklets, which can be downloaded along with video demonstrations of all exercises through the dedicated study website.

The exercise will involve 3 sessions per week of progressive moderate-to-high intensity resistance training for 8 major muscle groups of whole body, as well as progressively challenging static and dynamic balance training exercises suitable to their current level of stability.

The exercises may be broken up into sessions as short as 1 minute over the course of the day, and to enhance feasibility, integration into daily activities will be encouraged. For example, while watching TV, leg lifts and chair stands may be inserted during
commercial breaks, and progressively increased in difficulty. One-legged stands can be practiced while standing in front of kitchen and bathroom counters during hygiene and meal preparation activities.

Caregivers will be encouraged to perform the movements with their loved one, so that mimicking movements is all that is needed. One session per week will be viewed in real time by the remote trainer using Face Time on the iPad to allow direct feedback on form, triage questions, and provide health coaching. Daily exercise activities will also be logged on the HOMeCARE website on the iPad by the caregiver, which will have been programmed for automatic upload to the trainer.
Intervention code [1] 297164 0
Treatment: Other
Intervention code [2] 297165 0
Behaviour
Intervention code [3] 297166 0
Lifestyle
Comparator / control treatment
The control group dyads will continue to receive all usual care from their health care providers. They will be advised at the beginning of the study that those randomised to the control group will be on a waiting list to receive the experimental program at the end of 3 months.
Control group
Active

Outcomes
Primary outcome [1] 301072 0
Functional mobility via Short Physical Performance Battery (SPPB) for the adult with Dementia
Timepoint [1] 301072 0
Baseline and 3 months.
Primary outcome [2] 301073 0
State Mindfulness Scale score for the caregiver
Timepoint [2] 301073 0
Baseline, 4 weeks, 8 weeks, and 3 months.
Primary outcome [3] 301089 0
Zarit Burden Interview score for the caregiver
Timepoint [3] 301089 0
Baseline, 4 weeks, 8 weeks and 3 months.
Secondary outcome [1] 331660 0
Quality of life of the adult with dementia using the Dementia Quality of Life Measure (DEMQOL - Carer),
Timepoint [1] 331660 0
Baseline and at 3 months.
Secondary outcome [2] 331662 0
Caregiver depression measured through the Hospital Anxiety and Depression Scale
Timepoint [2] 331662 0
Baseline and at 3 months.
Secondary outcome [3] 331700 0
Caregiver movement and activities measured through an Actigraph accelerometer and Axivity monitor worn over 1 week.
Timepoint [3] 331700 0
Baseline and at 3 months.
Secondary outcome [4] 331701 0
Caregiver quality of life through the 36-Item Short Form Health Survey (SF-36)
Timepoint [4] 331701 0
Baseline and at 3 months.
Secondary outcome [5] 331723 0
Depressive symptoms for adult with dementia via the Geriatric Depression Scale (GDS),
Timepoint [5] 331723 0
Baseline and at 3 months.
Secondary outcome [6] 332219 0
Functional capacity and daily activity measures for adults with dementia using the Katz Index of Independence in Activities of Daily Living (KATZ ADL)
Timepoint [6] 332219 0
Baseline and at 3 months.
Secondary outcome [7] 332231 0
Cognition of the person with dementia through the NIH TOOLBOX adult cognition
Timepoint [7] 332231 0
Baseline and at 3 months.
Secondary outcome [8] 332236 0
Physical capacity of the adult with dementia through a one repetition maximum muscle strength testing leg press, knee extension, triceps, and seated row)
Timepoint [8] 332236 0
Baseline, and at 3 months.
Secondary outcome [9] 332237 0
For the person with dementia, habitual and maximal gait velocity with and without dual tasking. The variety of tasks will be used dependent on the level of cognitive impairment in the participant. These may include things such as set tests (animal naming), numerical or alphabet sequences, or calculations.
Timepoint [9] 332237 0
Baseline and at 3 months.
Secondary outcome [10] 332459 0
Sleep quality, quantity, and activity levels measured through an Actigraph accelerometer and Axivity monitor worn over 1 week.
Timepoint [10] 332459 0
Baseline and at 3 months.
Secondary outcome [11] 332460 0
Caregiver sleep quality via the Pittsburgh Sleep Quality Index
Timepoint [11] 332460 0
Baseline and at 3 months.
Secondary outcome [12] 332461 0
Caregiver sleep quality measured through Insomnia Severity Scale
Timepoint [12] 332461 0
Baseline and at 3 months.
Secondary outcome [13] 332462 0
Executive function of person with dementia through the Trail Making Test (TMT) A and B
Timepoint [13] 332462 0
Baseline and at 3 months.
Secondary outcome [14] 332463 0
Memory impairment of the person with dementia through the Hopkins Verbal Learning Test
Timepoint [14] 332463 0
Baseline and at 3 months.
Secondary outcome [15] 332464 0
Cognitive impairment of the person with dementia through the Mini-metal State Exam
Timepoint [15] 332464 0
Baseline and at 3 months.
Secondary outcome [16] 332465 0
Caregiver's affect through the Positive and Negative Affect Schedule (PANAS) mood states scale
Timepoint [16] 332465 0
Baseline and at 3 months.
Secondary outcome [17] 332467 0
Cognitive function, daily activity measures and instrumental daily activities of the adults with dementia using the Bayer Instrumental Activities of Daily Living (BAYER IADL)
Timepoint [17] 332467 0
Baseline and at 3 months.
Secondary outcome [18] 332468 0
Mobility of the adults with dementia using the Life-Space Assessment (proxy report via the caregiver)
Timepoint [18] 332468 0
Baseline and at 3 months.
Secondary outcome [19] 342370 0
Bioelectrical impedance analysis of the person with dementia.
Timepoint [19] 342370 0
Baseline and at 3 months.
Secondary outcome [20] 342371 0
Orthostatic Blood Pressure of the person with dementia.
Timepoint [20] 342371 0
Baseline and 3 months.
Secondary outcome [21] 342372 0
Nutrition status identified through the Mini Nutritional Assessment for the person with dementia.
Timepoint [21] 342372 0
Baseline and 3 months.

Eligibility
Key inclusion criteria
Each dyad will be composed of one caregiver and one participant with mild to moderate dementia for whom they provide care.

The participant with dementia must:
1) Live in the community,
2) Have at least one informal caregiver,
3) Have diagnosed mild-moderate dementia of any type (Mini-mental State Exam score 12-24/30),
4) Have mild deficits in functional mobility (walking, balance, chair stand) via the Short Physical Performance Battery [(SPPB) score <10/12],
5) Ambulatory over short distances without the assistance of a person.

The informal caregiver in the dyad (family or friend) must:
1) Live with the participant with dementia and/or providing some portion of their daily care including Activities of Daily Living in an informal capacity.
2) Be able to speak and understand English
3) Residence within 30 km of the clinic sites.
4) Adequate vision, hearing, cognition and manual dexterity sufficient to use the iPad programs developed for the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Either the person with Dementia or the caregiver must not have an unstable disease or rapidly progressive or terminal illness, resulting in their inability to perform any of the interventions.

For the participant with dementia:
1) Severe dementia (Mini-mental State Exam score <12)
2) Short Physical Performance Battery (SPPB) score of >10/12

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation using concealed, sequentially numbered envelopes opened by the participant after baseline assessment completed. Sequencing and randomization will be done by an external staff member not involved with the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dyads will be randomised after baseline assessment, stratified by level of SPPB (<7; 7-9) and MMSE (12-19, 20-24). Concealed, sequentially numbered envelopes will be opened by the participant after baseline assessment completed. Sequencing done by an external staff member not involved with the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An intention-to-treat analytic strategy will be used, allowing inclusion of all participants regardless of adherence or dropout without need for imputation. A mixed model analysis of covariance will be used to assess the main effects of changes over time and group x time interactions in both members of dyads, adjusted for age, gender, baseline function and burden and other characteristics found to be related to the variable of interest.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/06/2017
Actual
12/06/2017
Date of last participant enrolment
Anticipated
31/01/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
30
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295612 0
Other Collaborative groups
Name [1] 295612 0
Dementia Collaborative Research Centres (DCRC)
Country [1] 295612 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
University of Sydney
Cumberland Campus
75 East Street, Lidcombe, 2141
NSW, Australia
Country
Australia
Secondary sponsor category [1] 294452 0
None
Name [1] 294452 0
Address [1] 294452 0
Country [1] 294452 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296930 0
The University of Sydney Research Integrity & Ethics Administration
Ethics committee address [1] 296930 0
Ethics committee country [1] 296930 0
Australia
Date submitted for ethics approval [1] 296930 0
07/10/2016
Approval date [1] 296930 0
27/01/2017
Ethics approval number [1] 296930 0
2016/795

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1458 1458 0 0
/AnzctrAttachments/372352-1. Ethics Summary of Proposal HOMeCare.pdf (Supplementary information)
Attachments [2] 2399 2399 0 0
/AnzctrAttachments/372352-HOMeCare_PIS version 5_Person with dementia_06.10.17CLEAN.pdf (Participant information/consent)
Attachments [3] 2400 2400 0 0
/AnzctrAttachments/372352-HOMeCare PIS version 4_Caregiver_06.10.17CLEAN.pdf (Participant information/consent)

Contacts
Principal investigator
Name 72466 0
Prof Maria A. Fiatarone Singh, MD, FRACP
Address 72466 0
University of Sydney
K221, Cumberland Campus
75 East Street, Lidcombe, 2141
NSW, Australia
Country 72466 0
Australia
Phone 72466 0
+61 2 9351 9755
Fax 72466 0
+61 2 9351-9204
Email 72466 0
[email protected]
Contact person for public queries
Name 72467 0
Kenneth Daniel
Address 72467 0
University of Sydney
K220, Cumberland Campus
75 East Street, Lidcombe, 2141
NSW, Australia
Country 72467 0
Australia
Phone 72467 0
+61 2 9351 9655
Fax 72467 0
Email 72467 0
[email protected]
Contact person for scientific queries
Name 72468 0
Maria A. Fiatarone Singh, MD, FRACP
Address 72468 0
University of Sydney
K221, Cumberland Campus
75 East Street, Lidcombe, 2141
NSW, Australia
Country 72468 0
Australia
Phone 72468 0
+61 2 9351 9755
Fax 72468 0
+61 2 9351-9204
Email 72468 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy and ethics considerations for recruited participants in line with what has been approved by our ethics committee. Data would be available in de-identified form only.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1030Other    http://www.strongmindshomecare.org/



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCaring for Informal Dementia Caregivers and Their Loved Ones Via the HOMeCARE Exercise and Mindfulness for Health Program (HOMeCARE): A Randomized, Single-Blind, Controlled Trial.2023https://dx.doi.org/10.1177/23337214231203472
N.B. These documents automatically identified may not have been verified by the study sponsor.