Clinical trial NCT06203639: Evaluation of an App to Alleviate Stress Among Caregivers of People With Dementia
Official title: Development and Preliminary Evaluation of an App to Reduce Caregiver Stress and Burden Among Informal Caregivers of People Living With Dementia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Caregiver Burden
Keywords: Dementia
mobile app
Lead sponsor: University of Regina
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of the three group conditions: 1) UR Caregiver; 2) active control group; and 2) control group.
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at 8-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 8-week period)
measure: Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at a 4-week follow-up
timeFrame: The PSS-10 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow-up period
measure: Change from after the 8-week period in the Perceived Stress Scale-10 (PSS-10) total scores at a 4-week follow-up
timeFrame: The PSS-10 will be administered immediately after the 8-week period and at a 4-week follow-up period
measure: Change from baseline in the Burden Scale for Family Caregivers-Short Version (BSFC-S) total scores at 8-weeks
timeFrame: 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)
measure: Change from baseline in the BSFC-S total scores at a 4-week follow-up
timeFrame: The BSFC-S will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up
measure: Change from after the 8-week period in the BSFC-S total scores at a 4-week follow-up
timeFrame: The BSFC-S will be administered immediately after the 8-week period and at a 4-week follow-up period
measure: Change from baseline in the Patient Health Questionnaire-9 (PHQ-9) total scores at 8-weeks
timeFrame: 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)
measure: Change from baseline in the PHQ-9 total scores at a 4-week follow-up
timeFrame: The PHQ-9 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow-up period
measure: Change from after the 8-week period in the PHQ-9 total scores at a 4-week follow-up
timeFrame: The PHQ-9 will be administered immediately after the 8-week period and at a 4-week follow-up period
measure: Change from baseline in the Generalized Anxiety Disorder-7 (GAD-7) total scores at 8-weeks
timeFrame: 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)
measure: Change from baseline in the GAD-7 total scores at a 4-week follow-up
timeFrame: The GAD-7 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period
measure: Change from after the 8-week period in the GAD-7 total scores at a 4-week follow-up
timeFrame: The GAD-7 will be administered immediately after the 8-week period and at a 4-week follow-up period
Secondary outcomes:
measure: Change from baseline in the Multidimensional Scale for Perceived Social Support (MSPSS) total scores at 8-weeks
timeFrame: 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)
measure: Change from baseline in the MSPSS total scores at a 4-week follow-up
timeFrame: The MSPSS will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period
measure: Change from after the 8-week period in the MSPSS total scores at a 4-week follow-up
timeFrame: The MSPSS will be administered immediately after the 8-week period and at a 4-week follow-up period
measure: Change from baseline in the Caregiving Self-Efficacy Scale (CSES-8) total scores at 8-weeks
timeFrame: 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)
measure: Change from baseline in the CSES-8 total scores at a 4-week follow-up
timeFrame: The CSES-8 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period
measure: Change from after the 8-week period in the CSES-8 total scores at a 4-week follow-up
timeFrame: The CSES-8 will be administered immediately after the 8-week period and at a 4-week follow-up period
measure: Change from baseline in the Brief-Coping Orientation to Problems Experienced Inventory (Brief-COPE) subscale scores at 8-weeks
timeFrame: 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)
measure: Change from baseline in the Brief-COPE subscale scores at a 4-week follow-up
timeFrame: The Brief-COPE will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period
measure: Change from after the 8-week period in the Brief-COPE subscale scores at a 4-week follow-up
timeFrame: The Brief-COPE will be administered immediately after the 8-week period and at a 4-week follow-up period
Other outcomes:
Locations:
city: Regina
country: Canada
facility: University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Thomas Hadjistavropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
citation: Graessel E, Berth H, Lichte T, Grau H. Subjective caregiver burden: validity of the 10-item short version of the Burden Scale for Family Caregivers BSFC-s. BMC Geriatr. 2014 Feb 20;14:23. doi: 10.1186/1471-2318-14-23.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
citation: Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
citation: Ritter PL, Sheth K, Stewart AL, Gallagher-Thompson D, Lorig K. Development and Evaluation of the Eight-Item Caregiver Self-Efficacy Scale (CSES-8). Gerontologist. 2022 Mar 28;62(3):e140-e149. doi: 10.1093/geront/gnaa174.