NCT04226872

Brief Summary

When a person living with dementia moves into a long term care facility, their family members remain involved in their care. They learn new roles and make significant and often stressful adjustments. These caregivers are an at-risk group, and evidence suggests that their mental health may actually worsen after the person they are caring for moves into long term care. The research team previously created a free, web-based, interactive, intervention called My Tools 4 Care-In Care (MT4C-In Care) and tested it with 37 caregivers in Alberta. Caregivers found the toolkit to be easy to use, feasible, acceptable, and satisfactory, and reported increased hope and decreased loss and grief, after using it. Additionally, they reported that the toolkit helped them through the transitions they experience when their family member lives in long term care. In this next study we want to see if MT4C-In Care can improve the quality of life, hope, social support, self-efficacy, and decrease the loss, grief and loneliness of family caregivers. During phase 1 the existing MT4C-In Care toolkit was reviewed with input from family caregivers of persons living with dementia in long term care through focus group interviews. The toolkit is now being revised and will be tested, during phase 2, with 280 caregivers of persons living with dementia in long term care across 4 provinces in Canada (Alberta, Ontario, Saskatchewan, and Manitoba). These caregivers will be randomly assigned into an intervention (caregivers with access to MT4C-In Care) and a control group (no access to MT4C-In Care).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
234

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

4 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

First Submitted

Initial submission to the registry

January 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

February 3, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

February 2, 2023

Status Verified

September 1, 2022

Enrollment Period

1.4 years

First QC Date

January 9, 2020

Last Update Submit

January 31, 2023

Conditions

DementiaFamily

Keywords

CaregiversQuality of lifeDementiaWeb-based intervention

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the 12-item Short-Form Health Survey (SF-12v2) - Mental Component Summary Score at two and four months

    The SF-12v2 is a measure of health related quality of life and provides 2 scores 1) Mental Component Summary Score (MCS) and 2) Physical Component Summary Score (PCS). MCS scores range from 0 to 100, higher scores indicate better mental health related quality of life

    Baseline, 2 months, 4 months

Secondary Outcomes (6)

  • Change from baseline in the 12-item Short-Form Health Survey (SF-12v2) - Physical Component Summary Score at 2 and 4 months.

    Baseline, 2 months, 4 months

  • Change from baseline in the Herth Hope Index Score (HHI) at 2 and 4 months.

    Baseline, 2 months, 4 months

  • Change from baseline in the General Self-Efficacy Scale (GSES) at 2 and 4 months.

    Baseline, 2 months, 4 months

  • Change from baseline in the Non Death Revised Grief Experience Inventory (NDRGEI) at 2 and 4 months.

    Baseline, 2 months, 4 months

  • Change from baseline in 3 item loneliness score at 2 and 4 months.

    Baseline, 2 months, 4 months

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will receive access to My Tools for Care - In Care for 2 months. They will also receive a copy of the Alzheimer Society's "The Progression Of Alzheimer's Disease - Overview Booklet".

Behavioral: My Tools for Care - In Care

Control

NO INTERVENTION

The control group will not receive the intervention (i.e. they will not access My Tools for Care - In Care). They will receive a copy of the Alzheimer Society's "The Progression Of Alzheimer's Disease - Overview Booklet". Data collection for outcome variables will be the same as participants in the intervention group.

Interventions

My Tools for Care - In CareBEHAVIORAL

Self-administered web-based transition toolkit (My tools 4 Care - In Care) contains interactive activities and resources to help carers through transitions that they face after the person living with dementia has moved to a long-term care setting.

Intervention

Eligibility Criteria

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

You may qualify if:

  • Family caregivers (≥18 years of age) of a person ≥65 years of age who has dementia that lives in a long-term care home
  • English-speaking
  • Has a valid email address and access to a computer and internet.

You may not qualify if:

  • Family caregivers of a person under the age of 65, who does not have dementia, or who does not reside in a long-term care home
  • Care partner has died
  • Non-English speaking
  • Under 18 years of age
  • No internet access or valid email

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Of Alberta

Edmonton, Alberta, T6G 1C9, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 2Z4, Canada

Location

Related Publications (2)

  • Duggleby W, Jovel Ruiz K, Ploeg J, McAiney C, Peacock S, Nekolaichuk C, Holroyd-Leduc J, Ghosh S, Brazil K, Swindle J, Forbes D, Woodhead Lyons S, Parmar J, Kaasalainen S, Cottrell L, Paragg J. Mixed-methods single-arm repeated measures study evaluating the feasibility of a web-based intervention to support family carers of persons with dementia in long-term care facilities. Pilot Feasibility Stud. 2018 Oct 31;4:165. doi: 10.1186/s40814-018-0356-7. eCollection 2018.

    PMID: 30410783BACKGROUND

  • Duggleby W, O'Rourke H, Swindle J, Peacock S, McAiney C, Baxter P, Thompson G, Dube V, Nekolaichuk C, Ghosh S, Holroyd-Leduc J. Study protocol: pragmatic randomized control trial of my tools 4 care- in care (MT4C-in care) a web-based tool for family Carers of persons with dementia residing in long term care. BMC Geriatr. 2020 Aug 10;20(1):285. doi: 10.1186/s12877-020-01690-w.

    PMID: 32778059DERIVED

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

  • Hannah O'Rourke, 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

January 9, 2020

First Posted

January 13, 2020

Study Start

February 3, 2020

Primary Completion

June 30, 2021

Study Completion

October 31, 2021

Last Updated

February 2, 2023

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(4)