NCT02428387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

April 17, 2015

Last Update Submit

May 28, 2017

Conditions

Keywords

caregiversinterventionhealth related quality of lifedementia

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Health Related Quality of Life at One, Three and Six Months

    SF 12v2 Mental Component and Physical Component Score

    One, three and six months

Secondary Outcomes (2)

  • Change from Baseline in Hope at One, Three and Six Months

    one, three and six months

  • Change from Baseline in General Self Efficacy at One, Three and Six Months

    One, three and six months

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group (Group 1) will receive instructions on how to access "My Tools 4 Care" for 3 months.

Behavioral: My Tools 4 Care

Educational Control

NO INTERVENTION

An educational control group (Group 2) will receive a copy of the Alzheimer's Society' The Progression of Alzheimer's Disease - Overview Booklet.

Interventions

My Tools 4 CareBEHAVIORAL

On-line self-administered (My Tools 4 Care) transition toolkit includes interactive activities and resources to help caregivers deal with their transitions

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G 1C9, Canada

Location

Jenny Ploeg

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (5)

  • Duggleby W, Swindle J, Peacock S. Self-administered intervention for caregivers of persons with Alzheimer's disease. Clin Nurs Res. 2014 Feb;23(1):20-35. doi: 10.1177/1054773812474299. Epub 2013 Feb 6.

    PMID: 23393291BACKGROUND
  • Duggleby W, Ploeg J, McAiney C, Fisher K, Jovel Ruiz K, Ghosh S, Peacock S, Markle-Reid M, Williams A, Triscott J, Swindle J. A Comparison of Users and Nonusers of a Web-Based Intervention for Carers of Older Persons With Alzheimer Disease and Related Dementias: Mixed Methods Secondary Analysis. J Med Internet Res. 2019 Oct 17;21(10):e14254. doi: 10.2196/14254.

  • Markle-Reid M, Ploeg J, Valaitis R, Duggleby W, Fisher K, Fraser K, Ganann R, Griffith LE, Gruneir A, McAiney C, Williams A. Protocol for a program of research from the Aging, Community and Health Research Unit: Promoting optimal aging at home for older adults with multimorbidity. J Comorb. 2018 Jul 31;8(1):2235042X18789508. doi: 10.1177/2235042X18789508. eCollection 2018.

  • Duggleby W, Ploeg J, McAiney C, Peacock S, Fisher K, Ghosh S, Markle-Reid M, Swindle J, Williams A, Triscott JA, Forbes D, Jovel Ruiz K. Web-Based Intervention for Family Carers of Persons with Dementia and Multiple Chronic Conditions (My Tools 4 Care): Pragmatic Randomized Controlled Trial. J Med Internet Res. 2018 Jun 29;20(6):e10484. doi: 10.2196/10484.

  • Duggleby W, Ploeg J, McAiney C, Fisher K, Swindle J, Chambers T, Ghosh S, Peacock S, Markle-Reid M, Triscott J, Williams A, Forbes D, Pollard L. Study protocol: pragmatic randomized control trial of an internet-based intervention (My tools 4 care) for family carers. BMC Geriatr. 2017 Aug 14;17(1):181. doi: 10.1186/s12877-017-0581-6.

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Wendy Duggleby, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2015

First Posted

April 28, 2015

Study Start

April 1, 2015

Primary Completion

April 12, 2017

Study Completion

April 12, 2017

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations