NCT03571165

Brief Summary

Following institutionalization of a relative with Alzheimer's disease and related dementia (ADRD), family carers continue to provide care and must learn to negotiate with staff, and navigate the system, all of which can affect their mental health. A web-based intervention, My Tools 4 Care - In Care (MT4C-In Care) will be developed to aid carers through the transitions experienced when their frail older relative/friend with ADRD resides a in Long-Term Care Facility (LTC). A mixed method pre-post-test longitudinal feasibility study will be used to evaluate MT4C-In Care for feasibility, acceptability, ease of use, and satisfaction. In addition, the investigators expect that MT4C-In Care will improve carers hope, general self-efficacy, quality of life, and reduce their feelings of loss and grief. Following baseline data collection 40 carers of persons with ADRD will be given access to MT4C-In Care over a 2 month period. Measures will be collected at baseline, 1, and 2 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

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

June 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

June 17, 2018

Last Update Submit

April 3, 2023

Conditions

Keywords

carersquality 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 one and two 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, 1 month, and 2 months

Secondary Outcomes (4)

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

    baseline, 1 month, and 2 months

  • Change from baseline in the Herth Hope Index Score (HHI) at one and two months

    baseline, 1 month, 2 months

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

    baseline, 1 month, 2 months

  • Change from baseline in the Non Death Revised Grief Experience Inventory (NDRGEI) at one and two months

    baseline, 1 month, 2 months

Study Arms (1)

Intervention

EXPERIMENTAL

The intervention group received information on accessing My Tools 4 Care - In Care for 2 months.

Behavioral: My Tools 4 Care - In Care

Interventions

Self-administered web-based transition toolkit (My tools 4 Care - In Care) contains interactive activities and resources to help carers through transitions.

Intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • family/friend carer of a person with ADRD, 65 years of age or older, residing in a 24-hour care facility
  • years of age or older
  • English speaking
  • access to the internet and an email account.

You may not qualify if:

  • family/friend of a person under the age of 65, who does not have ADRD, or who is not residing in a 24-hour care facility;
  • no internet access or email account.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Alberta

Edmonton, Alberta, T6G 1C9, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Wendy D Duggleby, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2018

First Posted

June 27, 2018

Study Start

June 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

April 4, 2023

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations