Clinical trial NCT05217004: Evaluation of Mobile Apps for Informal Caregivers of People Living With Dementia
Official title: Systematic Evaluation of Mobile Applications for Informal Caregivers of People Living With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Burden
Stress
Dementia
Keywords: Apps
mhealth
Lead sponsor: University of Regina
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the effectiveness of two currently available apps for unpaid caregivers of people living with dementia.

Detailed description: Informal caregivers of people living with dementia experience stressors that are associated with adverse health outcomes. Mobile applications (i.e., apps) could potentially improve the delivery and increase access to interventions. Although apps for informal caregivers of people living with dementia are available, empirical evidence to support their effectiveness is limited. The evaluation will be conducted by recruiting informal caregivers of people living with dementia. Participants will be randomly assigned to one of the two app-using groups or a wait-list condition. In the rare event that a participant experiences issues downloading an assigned app (and before commencing the 2-week period), participants will be randomly assigned to one of the other two conditions. Participants in the app-using groups will be asked to use their app for a 2-week period, and burden, stress, overall health, and knowledge will be assessed before, after the 2-week period, and at a 3-week follow-up. Subjective app ratings and usability of apps will be collected after the 2-week period. A 3 between (group) by 3 within (time: baseline, post, follow-up) mixed model (repeated measures) multivariate analysis of variance and univariate analyses will be conducted to examine improvements on outcome measures over time. Interviews will be conducted, and textual data will be analyzed thematically to examine caregiver experiences, perceptions of caregivers in using selected apps, and preferences and needs of caregivers in the development of future apps. Findings from the proposed investigation can help guide caregivers in choosing the apps that best address their needs. Moreover, findings from the investigation can inform future developments of apps to address the needs of caregivers of people living with dementia.

Eligibility criteria: Inclusion Criteria:

* providing informal care for a person living with dementia (e.g., informal caregivers who are non-professionals; this may include immediate family members such as spouses, children, and other relatives, friends)
* living with or providing primary care for the person living with dementia (i.e., the care recipient is not in a long-term care facility)
* providing unpaid care
* own a smartphone (i.e., an iPhone or Android and/or can access either IOS or Android platforms)

Exclusion Criteria:

- using an app for caregiver stress/burden

Primary outcomes:
measure: Change from baseline in the Zarit Caregiver Burden Interview (ZBI) total scores at 2 weeks
timeFrame: The ZBI will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 2-week period).
measure: Change from baseline in the Zarit Caregiver Burden Interview (ZBI) total scores at a 3-week follow up period
timeFrame: The ZBI will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period.
measure: Change from after the 2-week period in the Zarit Caregiver Burden Interview (ZBI) total scores at a 3-week follow up period
timeFrame: The ZBI will be administered after a 2-week period and at a 3-week follow-up period.
measure: Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at 2 weeks
timeFrame: The PSS-10 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 2-week period).
measure: Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at a 3-week follow up period
timeFrame: The PSS-10 will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period.
measure: Change from after a 2-week period on the Perceived Stress Scale-10 (PSS-10) total scores at a 3-week follow up period
timeFrame: The PSS-10 will be administered after a 2-week period and at a 3-week follow-up period.
measure: Change from baseline in the Short-Form Health Survey-12 (SF-12) scores at 2 weeks
timeFrame: The SF-12 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 2-week period).
measure: Change from baseline in the Short-Form Health Survey-12 (SF-12) scores at a 3-week follow up period
timeFrame: The SF-12 will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period.
measure: Change from after a 2-week period in the Short-Form Health Survey-12 (SF-12) scores at a 3-week follow up period
timeFrame: The SF-12 will be administered immediately after the end of the intervention period (i.e., after a 2-week period) and at a 3-week follow-up period.
measure: Change from baseline in the Dementia Knowledge Assessment Tool Version 2 (DKAT2) total scores at 2 weeks
timeFrame: The DKAT2 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 2-week period).
measure: Change from baseline in the Dementia Knowledge Assessment Tool Version 2 (DKAT2) total scores at a 3-week follow up period
timeFrame: The DKAT2 will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period.
measure: Change from after a 2-week period in the Dementia Knowledge Assessment Tool Version 2 (DKAT2) total scores at a 3-week follow up period
timeFrame: The DKAT2 will be administered immediately after the end of the intervention period (i.e., after a 2-week period) and at a 3-week follow-up period.
Secondary outcomes:
measure: Total System Usability Scale (SUS) score after the 2 week period
timeFrame: The SUS will be administered after the end of the intervention period (i.e., after a 2 week period) for app-using participants.
measure: Total Mobile App Rating Scale Subjective App Quality score after the 2 week period
timeFrame: The MARS Subjective App Quality Rating will be administered after the end of the intervention period (i.e., after a 2-week period) for app-using participants.
Other outcomes:
Locations:
city: Regina
country: Canada
facility: University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Louise IR Castillo, BSc (Hons)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Regina
name: Thomas Hadjistavropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
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