Evaluation of an App to Alleviate Stress Among Caregivers of People With Dementia

April 9, 2026 updated by: University of Regina

Development and Preliminary Evaluation of an App to Reduce Caregiver Stress and Burden Among Informal Caregivers of People Living With Dementia

Caregivers of people living with dementia experience significant stress which can negatively affect their mental health. The goal of our study is to test a newly developed app that focuses on providing stress management strategies for caregivers of people living with dementia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Caregivers of people living with dementia experience significant stress which can negatively affect their mental health. Psychological interventions that focus on building skills and providing strategies to improve their well-being have been shown to improve caregiver well-being. Although mobile applications (apps) are available for caregivers of people living with dementia, existing apps do not adequately address the stress and mental health needs experienced by caregivers of people living with dementia. In addition, there is a paucity of mobile app interventions that provide practical stress management strategies for caregivers. The goal of the study is to conduct an evaluation of a novel app (UR Caregiver) that focuses on providing stress management strategies for caregivers of people living with dementia. The app utilizes cognitive behavioural principles and is consistent with models of stress and coping. Caregivers of people living with dementia will be recruited and randomly assigned to three groups: 1) UR Caregiver; 2) active control; and 3) non-app using control. Participants in the app-using groups will be asked to use the app over an 8-week period. Stress, burden, and mental health will be assessed before, after the 8-week period, and at a follow-up 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. Given the demands that caregivers of people living with dementia face daily, the creation and evaluation of an app that aims to provide stress-management strategies has the potential of improving the quality of life of caregivers of people living with dementia.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4S 0A2
        • University of Regina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. caregivers providing informal and unpaid care (e.g., spouses, children, relatives) for a person living with dementia
  2. providing primary care (i.e., most of the care or equally shares the care with another individual such as a mother or sibling) for the person living with dementia
  3. own a smartphone/tablet (i.e., can access either IOS or Android platforms).

Exclusion Criteria:

1) Currently using an app for caregiver stress/burden

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: UR Caregiver group
Participants will be asked to use the UR Caregiver app daily (e.g., at least 15 minutes/day) for 8 weeks and complete and practice one module per week. On the eighth week, participants will be asked to review one of the past modules of their choice.
Other: UR Caregiver
The UR Caregiver app was informed by previous research and developed in collaboration with caregiver partners. The app utilizes cognitive behavioural principles and is consistent with models of stress and coping. The app consists of seven modules. The app is available on IOS and Googe Play store. In addition to the didactic information provided in the app, worksheets are available in each module to practice the strategy/skill provided.
Active Comparator: Active control
Participants will be asked to use the app daily (e.g., at least 15 minutes/day) for an 8-week period.
Other: CLEAR Dementia Care
A subset of participants will be randomly assigned to use the CLEAR Dementia Care app as part of an active control group. The app consists of features that primarily address care-related needs (as opposed to stress management strategies) allowing for a comparison with the UR Caregiver app. The app was developed by the Northern Health and Social Care Trust (Northern Ireland) and is freely available on both IOS and Google Play stores. The CLEAR Dementia Care app provides users with information about dementia (e.g., the different types of dementia, how dementia affects the brain, and symptoms associated with dementia). The app offers suggestions and alternative approaches to various care-related situations through illustrations/images that caregivers may experience.
No Intervention: Non-app using control
Participants in this group will not be using any apps in the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at 8-weeks
Time Frame: 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 8-week period)
Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload over the past month. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress
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 8-week period)
Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at a 4-week follow-up
Time Frame: The PSS-10 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow-up period
Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload over the past month. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress
The PSS-10 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow-up period
Change from after the 8-week period in the Perceived Stress Scale-10 (PSS-10) total scores at a 4-week follow-up
Time Frame: The PSS-10 will be administered immediately after the 8-week period and at a 4-week follow-up period
Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload over the past month. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress
The PSS-10 will be administered immediately after the 8-week period and at a 4-week follow-up period
Change from baseline in the Burden Scale for Family Caregivers-Short Version (BSFC-S) total scores at 8-weeks
Time Frame: The BSFC-S 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 8-week period)
Subjective caregiver burden will be assessed using the BSFC-S. The BSFC-S is a 10-item scale developed to assess subjective burden. The BSFC-S was derived from the original 28-item scale. Each item is rated on a scale from 0 (Strongly disagree) to 3 (Strongly agree). Responses are summed with total scores ranging from 0 to 30 points with higher scores indicating greater caregiver burden
The BSFC-S 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 8-week period)
Change from baseline in the BSFC-S total scores at a 4-week follow-up
Time Frame: The BSFC-S will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up
Subjective caregiver burden will be assessed using the BSFC-S. The BSFC-S is a 10-item scale developed to assess subjective burden. The BSFC-S was derived from the original 28-item scale. Each item is rated on a scale from 0 (Strongly disagree) to 3 (Strongly agree). Responses are summed with total scores ranging from 0 to 30 points with higher scores indicating greater caregiver burden
The BSFC-S will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up
Change from after the 8-week period in the BSFC-S total scores at a 4-week follow-up
Time Frame: The BSFC-S will be administered immediately after the 8-week period and at a 4-week follow-up period
Subjective caregiver burden will be assessed using the BSFC-S. The BSFC-S is a 10-item scale developed to assess subjective burden. The BSFC-S was derived from the original 28-item scale. Each item is rated on a scale from 0 (Strongly disagree) to 3 (Strongly agree). Responses are summed with total scores ranging from 0 to 30 points with higher scores indicating greater caregiver burden
The BSFC-S will be administered immediately after the 8-week period and at a 4-week follow-up period
Change from baseline in the Patient Health Questionnaire-9 (PHQ-9) total scores at 8-weeks
Time Frame: The PHQ-9 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 8-week period)
The PHQ-9 is a 9-item self-report instrument widely used to assess for the presence and frequency of depressive symptoms over the last two weeks. Each of the nine items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 27) is calculated with increasing scores indicating greater depressive symptoms.
The PHQ-9 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 8-week period)
Change from baseline in the PHQ-9 total scores at a 4-week follow-up
Time Frame: The PHQ-9 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow-up period
The PHQ-9 is a 9-item self-report instrument widely used to assess for the presence and frequency of depressive symptoms over the last two weeks. Each of the nine items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 27) is calculated with increasing scores indicating greater depressive symptoms.
The PHQ-9 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow-up period
Change from after the 8-week period in the PHQ-9 total scores at a 4-week follow-up
Time Frame: The PHQ-9 will be administered immediately after the 8-week period and at a 4-week follow-up period
The PHQ-9 is a 9-item self-report instrument widely used to assess for the presence and frequency of depressive symptoms over the last two weeks. Each of the nine items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 27) is calculated with increasing scores indicating greater depressive symptoms.
The PHQ-9 will be administered immediately after the 8-week period and at a 4-week follow-up period
Change from baseline in the Generalized Anxiety Disorder-7 (GAD-7) total scores at 8-weeks
Time Frame: The GAD-7 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 8-week period)
The GAD-7 is a 7-item self-report instrument widely used to assess for anxiety symptoms. Each of the seven items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 21) is calculated with increasing scores indicating greater anxiety symptoms.
The GAD-7 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 8-week period)
Change from baseline in the GAD-7 total scores at a 4-week follow-up
Time Frame: The GAD-7 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period
The GAD-7 is a 7-item self-report instrument widely used to assess for anxiety symptoms. Each of the seven items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 21) is calculated with increasing scores indicating greater anxiety symptoms.
The GAD-7 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period
Change from after the 8-week period in the GAD-7 total scores at a 4-week follow-up
Time Frame: The GAD-7 will be administered immediately after the 8-week period and at a 4-week follow-up period
The GAD-7 is a 7-item self-report instrument widely used to assess for anxiety symptoms. Each of the seven items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 21) is calculated with increasing scores indicating greater anxiety symptoms.
The GAD-7 will be administered immediately after the 8-week period and at a 4-week follow-up period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in the Multidimensional Scale for Perceived Social Support (MSPSS) total scores at 8-weeks
Time Frame: The MSPSS 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 8-week period)
The MSPSS is a 12-item self-report scale that measures perceived social support across three areas (e.g., family, friends and significant others. Each item is rated on a 7-point Likert scale with responses ranging from 1 (very strongly disagree) to 7 (very strongly agree). Item ratings are summed with total scores ranging from 12-84 and higher scores indicating greater perceived support.
The MSPSS 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 8-week period)
Change from baseline in the MSPSS total scores at a 4-week follow-up
Time Frame: The MSPSS will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period
The MSPSS is a 12-item self-report scale that measures perceived social support across three areas (e.g., family, friends and significant others. Each item is rated on a 7-point Likert scale with responses ranging from 1 (very strongly disagree) to 7 (very strongly agree). Item ratings are summed with total scores ranging from 12-84 and higher scores indicating greater perceived support.
The MSPSS will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period
Change from after the 8-week period in the MSPSS total scores at a 4-week follow-up
Time Frame: The MSPSS will be administered immediately after the 8-week period and at a 4-week follow-up period
The MSPSS is a 12-item self-report scale that measures perceived social support across three areas (e.g., family, friends and significant others. Each item is rated on a 7-point Likert scale with responses ranging from 1 (very strongly disagree) to 7 (very strongly agree). Item ratings are summed with total scores ranging from 12-84 and higher scores indicating greater perceived support.
The MSPSS will be administered immediately after the 8-week period and at a 4-week follow-up period
Change from baseline in the Caregiving Self-Efficacy Scale (CSES-8) total scores at 8-weeks
Time Frame: The CSES-8 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 8-week period)
The CSES-8 is an 8-item self-report measure that measures caregiver self-efficacy. Respondents are asked to indicate their level of confidence in response to each item from 1 (not at all confident) to 10 (totally confident). Accordingly, a single score is calculated by averaging the responses for the items (i.e., possible scores range from 1-10) with higher mean scores indicating higher self-efficacy.
The CSES-8 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 8-week period)
Change from baseline in the CSES-8 total scores at a 4-week follow-up
Time Frame: The CSES-8 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period
The CSES-8 is an 8-item self-report measure that measures caregiver self-efficacy. Respondents are asked to indicate their level of confidence in response to each item from 1 (not at all confident) to 10 (totally confident). Accordingly, a single score is calculated by averaging the responses for the items (i.e., possible scores range from 1-10) with higher mean scores indicating higher self-efficacy.
The CSES-8 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period
Change from after the 8-week period in the CSES-8 total scores at a 4-week follow-up
Time Frame: The CSES-8 will be administered immediately after the 8-week period and at a 4-week follow-up period
The CSES-8 is an 8-item self-report measure that measures caregiver self-efficacy. Respondents are asked to indicate their level of confidence in response to each item from 1 (not at all confident) to 10 (totally confident). Accordingly, a single score is calculated by averaging the responses for the items (i.e., possible scores range from 1-10) with higher mean scores indicating higher self-efficacy.
The CSES-8 will be administered immediately after the 8-week period and at a 4-week follow-up period
Change from baseline in the Brief-Coping Orientation to Problems Experienced Inventory (Brief-COPE) subscale scores at 8-weeks
Time Frame: The Brief-COPE 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 8-week period)
Brief-COPE is a 28-item measure developed to assess different coping strategies used by individuals in response to stress. Three subscales can be obtained accordingly: emotion-focused, problem-focused, and dysfunctional subscale.
The Brief-COPE 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 8-week period)
Change from baseline in the Brief-COPE subscale scores at a 4-week follow-up
Time Frame: The Brief-COPE will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period
Brief-COPE is a 28-item measure developed to assess different coping strategies used by individuals in response to stress. Three subscales can be obtained accordingly: emotion-focused, problem-focused, and dysfunctional subscale.
The Brief-COPE will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period
Change from after the 8-week period in the Brief-COPE subscale scores at a 4-week follow-up
Time Frame: The Brief-COPE will be administered immediately after the 8-week period and at a 4-week follow-up period
Brief-COPE is a 28-item measure developed to assess different coping strategies used by individuals in response to stress. Three subscales can be obtained accordingly: emotion-focused, problem-focused, and dysfunctional subscale.
The Brief-COPE will be administered immediately after the 8-week period and at a 4-week follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Regina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Hadjistavropoulos, PhD, University of Regina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Non-identified numeric data will be made available to other researchers, following the publication of the results, upon reasonable request for a period of at least 7 years. Textual data from the interviews will not be shared to protect participant anonymity.

IPD Sharing Time Frame

The data will be made available to other researchers, following the publication of the results, upon reasonable request for a period of at least 7 years.

IPD Sharing Access Criteria

Requests by researchers who wish to access the data can be directed to Thomas.Hadjistavropoulos@uregina.ca

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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