DementiaNCT03571165
Feasibility Study of "My Tools 4 Care-In Care" for Family Caregivers of Residential-Living Older Persons With Dementia
A study testing My Tools 4 Care - In Care in people with Dementia and Family, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- What is being tested?
- My Tools 4 Care - In Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- family/friend carer of a person with ADRD, 65 years of age or older, residing in a 24-hour care facility
- 18 years of age or older
- English speaking
- access to the internet and an email account.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of an On-Line Intervention "My Tools 4 Care - In Care" for Family Caregivers of Residential-Living Older Persons With Dementia
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.
Read the detailed description
Background: Those who are admitted to long term care facilities (LTC) often have complex health needs making them frail and vulnerable. In addition, most have dementia. Families (broadly defined to include friends) continue to provide care after their relative is admitted to LTC with the added dimensions of negotiating with staff in the provision of care and learning to navigate the system. Family caregivers of persons with dementia experience negative physical and psychological well-being as a result of caregiving and their mental health may actually worsen after the institutionalization of a family member. The research team developed and is currently testing a web-based intervention My tools 4 Care (MT4C) for carers of persons with dementia and multiple chronic conditions in the community. MT4C is an interactive toolkit intended to help caregivers with their transitions. The research team was approached by family caregivers of persons with dementia in LTC to develop a toolkit tailored to their needs. The investigators expect that this new toolkit My Tools 4 Care-In Care (MT4C - In Care) will help users through significant changes and improve caregiver outcomes.
Research Questions: 1) What revisions should be made to My Tools 4 Care to tailor it to the needs of caregivers of older frail persons with dementia residing in LTC?, 2) What are the family caregivers' perceptions of the acceptability, feasibility, ease of use, and satisfaction with the toolkit? 3) How do study participants describe their hope, general self-efficacy, loss and grief and quality of life over time while participating in the study?, and 4) What is the use and cost of health services by the study participants?
Sample: Participant recruitment will take place from January 2017 to February 2017, using several strategies. Participants from another study who consented to be contacted for future relevant studies and who had a family member with ADRD residing in LTC will be contacted. Other forms of recruitment will include newspaper ads in two cities in Alberta, Canada and the Alzheimer Society of Alberta \& NWT e-newsletter along with dissemination of study pamphlets to family carers attending the organization's events.
Eligible participants will be contacted by trained Research Assistants who will explain the study and obtain verbal informed consent over the telephone to participate in the study.
Design: The study will involve 3 phases. Phase 1 will consist of focus group interviews with 6-8 family carers of persons with Alzheimer's disease and related dementias (ADRD) residing in LTC. These carers will be asked to review MT4C and answer open-ended questions to provide recommendations for change. During phase 2 MT4C-In Care will be developed based on information gathered during phase1 and input from a community advisory committee. In partnership with information technology web-developers (ATMIST), the new toolkit will be available in an online format. Phase 3 will use a mixed method pre-post-test longitudinal feasibility study. Forty carers of persons with ADRD will be given access to MT4C-In Care, following informed consent and baseline measures. Participants will be instructed to use MT4C-In Care at their convenience over a 2-month period. Information on participants use of MT4C-In Care will be collected with a checklist at 1 and 2 months. Outcome measures of hope, general self-efficacy, loss and grief, and quality of life will be collected at baseline, 1 month, and 2 months. As well, participants will be asked to complete a questionnaire at baseline and 2 months regarding their use of health and social services. Finally, at 2 months participants will complete a qualitative interview regarding the ease of use, feasibility, acceptability, and satisfaction with the toolkit and recommendations for revisions to the toolkit. All data collection will take place over the telephone and will be audio-recorded.
- Being tested
- My Tools 4 Care - In Care
- Keywords
- carers, quality of life, dementia, web-based intervention
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Tools 4 Care - In CareBehavioural
Self-administered web-based transition toolkit (My tools 4 Care - In Care) contains interactive activities and resources to help carers through transitions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group received information on accessing My Tools 4 Care - In Care for 2 months. Receives: Behavioral: My Tools 4 Care - In Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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). PCS scores range from 0 to 100, higher scores indicate better physical health related quality of life.
Measured: baseline, 1 month, and 2 months
Change from baseline in the Herth Hope Index Score (HHI) at one and two months
The HHI is a 12-item Likert-type scale used to measure hope. Items are scored from 1 "strongly disagree" to 4 "strongly agree", total scores range from 12 to 48 with a higher scores indicating greater hope. The items in the scale can be further divided into three factors of hope a) temporality and future, b) positive readiness and expectancy, and c) interconnectedness. Factor scores range from 4 to 16.
Measured: baseline, 1 month, 2 months
Change from baseline in the General Self-Efficacy Scale (GSES) at one and 2 months
The GSES is a 10 item 4-point scale. The scale assesses a person's perceived self-efficacy-their belief that they can complete novel or difficult tasks or cope with diversity. Total scores range from 10 to 40 with higher scores indicating a greater level of self-efficacy.
Measured: baseline, 1 month, 2 months
Change from baseline in the Non Death Revised Grief Experience Inventory (NDRGEI) at one and two months
The NDRGEI is a 22 item scale scored on a 6-point Likert scale from slightly disagree to strongly agree. The scale measures the grief experiences of persons anticipating a loss through four domains a) existential concerns (scores range 6-36), b) depression (scores range from 6-36), c) tension and guilt (scores range from 3-18), and d) physical distress (scores range from 7-42). The scale also offers a total grief score by calculating the sum of the four domains. The range for the total score is 22-132; higher scores indicate lower grief.
Measured: baseline, 1 month, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study startJun 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Frailty Network
- Responsible party
- Sponsor
- Investigators
- Wendy D Duggleby, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571165
- Sponsor's protocol ID
- Pro00065220
- Status last verified
- Mar 2020
- First submitted
- 17 Jun 2018
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30410783
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of an On-Line Intervention "My Tools 4 Care - In Care" for Family Caregivers of Residential-Living Older Persons With Dementia
- ClinicalTrials.gov ID
- NCT03571165
- Acronym / sponsor ID
- Pro00065220
- Keywords
- carers, quality of life, dementia, web-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Frailty Network
- Study start
- Jun 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Those who are admitted to long term care facilities (LTC) often have complex health needs making them frail and vulnerable. In addition, most have dementia. Families (broadly defined to include friends) continue to provide care after their relative is admitted to LTC with the added dimensions of negotiating with staff in the provision of care and learning to navigate the system. Family caregivers of persons with dementia experience negative physical and psychological well-being as a result of caregiving and their mental health may actually worsen after the institutionalization of a family member. The research team developed and is currently testing a web-based intervention My tools 4 Care (MT4C) for carers of persons with dementia and multiple chronic conditions in the community. MT4C is an interactive toolkit intended to help caregivers with their transitions. The research team was approached by family caregivers of persons with dementia in LTC to develop a toolkit tailored to their needs. The investigators expect that this new toolkit My Tools 4 Care-In Care (MT4C - In Care) will help users through significant changes and improve caregiver outcomes.
Research Questions: 1) What revisions should be made to My Tools 4 Care to tailor it to the needs of caregivers of older frail persons with dementia residing in LTC?, 2) What are the family caregivers' perceptions of the acceptability, feasibility, ease of use, and satisfaction with the toolkit? 3) How do study participants describe their hope, general self-efficacy, loss and grief and quality of life over time while participating in the study?, and 4) What is the use and cost of health services by the study participants?
Sample: Participant recruitment will take place from January 2017 to February 2017, using several strategies. Participants from another study who consented to be contacted for future relevant studies and who had a family member with ADRD residing in LTC will be contacted. Other forms of recruitment will include newspaper ads in two cities in Alberta, Canada and the Alzheimer Society of Alberta \& NWT e-newsletter along with dissemination of study pamphlets to family carers attending the organization's events.
Eligible participants will be contacted by trained Research Assistants who will explain the study and obtain verbal informed consent over the telephone to participate in the study.
Design: The study will involve 3 phases. Phase 1 will consist of focus group interviews with 6-8 family carers of persons with Alzheimer's disease and related dementias (ADRD) residing in LTC. These carers will be asked to review MT4C and answer open-ended questions to provide recommendations for change. During phase 2 MT4C-In Care will be developed based on information gathered during phase1 and input from a community advisory committee. In partnership with information technology web-developers (ATMIST), the new toolkit will be available in an online format. Phase 3 will use a mixed method pre-post-test longitudinal feasibility study. Forty carers of persons with ADRD will be given access to MT4C-In Care, following informed consent and baseline measures. Participants will be instructed to use MT4C-In Care at their convenience over a 2-month period. Information on participants use of MT4C-In Care will be collected with a checklist at 1 and 2 months. Outcome measures of hope, general self-efficacy, loss and grief, and quality of life will be collected at baseline, 1 month, and 2 months. As well, participants will be asked to complete a questionnaire at baseline and 2 months regarding their use of health and social services. Finally, at 2 months participants will complete a qualitative interview regarding the ease of use, feasibility, acceptability, and satisfaction with the toolkit and recommendations for revisions to the toolkit. All data collection will take place over the telephone and will be audio-recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: My Tools 4 Care - In CareThe intervention group received information on accessing My Tools 4 Care - In Care for 2 months. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- family/friend carer of a person with ADRD, 65 years of age or older, residing in a 24-hour care facility
- 18 years of age or older
- English speaking
- access to the internet and an email account.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My Tools 4 Care - In CareSelf-administered web-based transition toolkit (My tools 4 Care - In Care) contains interactive activities and resources to help carers through transitions. | Behavioural | Intervention |
Primary outcome
Change from baseline in the 12-item Short-Form Health Survey (SF-12v2) - Mental Component Summary Score at one and two months
Time frame: baseline, 1 month, and 2 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.
4 secondary outcomes
Change from baseline in the 12-item Short-Form Health Survey (SF-12v2) - Physical Component Summary Score at one and two months
Time frame: baseline, 1 month, and 2 months
Change from baseline in the Herth Hope Index Score (HHI) at one and two months
Time frame: baseline, 1 month, 2 months
Change from baseline in the General Self-Efficacy Scale (GSES) at one and 2 months
Time frame: baseline, 1 month, 2 months
Change from baseline in the Non Death Revised Grief Experience Inventory (NDRGEI) at one and two months
Time frame: baseline, 1 month, 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 30410783Duggleby 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy D Duggleby, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Tools 4 Care - In Care in people with Dementia and Family, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the 12-item Short-Form Health Survey (SF-12v2) - Mental Component Summary Score at one and two months (time frame: baseline, 1 month, and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03571165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.