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Evaluation of "My Tools 4 Care" for Family Caregivers of Persons With Dementia

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ClinicalTrials.gov Identifier: NCT02428387
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : May 31, 2017
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

With the number of Canadians with Alzheimer's disease and related dementias (ADRD) growing, supporting family care partners of persons with ADRD is critical. Family caregivers provide about 90 per cent of in-home care for persons with ADRD, and the care is often difficult due to co-morbidities in persons with ADRD. Family caregivers of older persons with ADRD and multiple chronic conditions (MCC) experience significant, complex, distressing transitions such as changes to their environment, roles and relationships, physical and mental health, isolation, and taking on new tasks. An online Transition Toolkit (My Tools 4 Care) was developed for family caregivers of persons with ADRD and MCC living at home, to support caregivers through transitions and increase their self-efficacy, hope, and quality of life (QOL).

Through this pragmatic mixed methods randomized controlled trial the investigators expect to find that family caregivers receiving the online My Tools 4 Care Toolkit will show greater improvement in hope, self-efficacy and QOL, at no additional cost from a societal perspective, compared with those in an educational control group. Following baseline data collection 180 participants will be randomly assigned to one of the groups with repeated measures at one, three and six months.


Condition or disease Intervention/treatment Phase
Family Dementia Behavioral: My Tools 4 Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Evaluation of a Transition Intervention for Family Caregivers of Persons With Alzheimer Disease and Multiple Chronic Conditions
Study Start Date : April 2015
Actual Primary Completion Date : April 12, 2017
Actual Study Completion Date : April 12, 2017


Arm Intervention/treatment
Experimental: Intervention
The intervention group (Group 1) will receive instructions on how to access "My Tools 4 Care" for 3 months.
Behavioral: My Tools 4 Care
On-line self-administered (My Tools 4 Care) transition toolkit includes interactive activities and resources to help caregivers deal with their transitions

No Intervention: Educational Control
An educational control group (Group 2) will receive a copy of the Alzheimer's Society' The Progression of Alzheimer's Disease - Overview Booklet.



Primary Outcome Measures :
  1. Change from Baseline in Health Related Quality of Life at One, Three and Six Months [ Time Frame: One, three and six months ]
    SF 12v2 Mental Component and Physical Component Score


Secondary Outcome Measures :
  1. Change from Baseline in Hope at One, Three and Six Months [ Time Frame: one, three and six months ]
    Herth Hope Index

  2. Change from Baseline in General Self Efficacy at One, Three and Six Months [ Time Frame: One, three and six months ]
    General Self-Efficacy Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Family caregivers of persons >65 years of age who have AD and related dementias (ADRD) and MCC (two or more chronic conditions)
  • English-speaking
  • Family or friends ≥ 18 years of age who provide physical, emotional, or financial care to persons with ADRD and MCC
  • Access and able to use a computer (and have an email address).

Exclusion Criteria:

Family caregivers caring for a person with ADRD and MCC who:

  • Has died
  • Resides in a Long Term Care Facility (nursing home)
  • Is hospitalized and designated as restorative care (Alberta) or alternate level of care (Ontario)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428387


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 1C9
Canada, Ontario
Jenny Ploeg
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
University of Alberta
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Wendy Duggleby, PhD University of Alberta
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02428387    
Other Study ID Numbers: Pro00048721
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Alberta:
caregivers
intervention
health related quality of life
dementia
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders