Dementia Clinical Trial
Official title:
Systematic Evaluation of Mobile Applications for Informal Caregivers of People Living With Dementia
NCT number | NCT05217004 |
Other study ID # | 2021-177 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 31, 2022 |
Est. completion date | July 5, 2022 |
Verified date | February 2022 |
Source | University of Regina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the effectiveness of two currently available apps for unpaid caregivers of people living with dementia.
Status | Completed |
Enrollment | 175 |
Est. completion date | July 5, 2022 |
Est. primary completion date | May 27, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Regina | Regina | Saskatchewan |
Lead Sponsor | Collaborator |
---|---|
University of Regina |
Canada,
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Wozney L, Freitas de Souza LM, Kervin E, Queluz F, McGrath PJ, Keefe J. Commercially Available Mobile Apps for Caregivers of People With Alzheimer Disease or Other Related Dementias: Systematic Search. JMIR Aging. 2018 Dec 7;1(2):e12274. doi: 10.2196/12274. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in the Zarit Caregiver Burden Interview (ZBI) total scores at 2 weeks | Caregiver burden will be assessed using the ZBI. The ZBI is a 22-item self-report questionnaire designed to measure the extent of the burden experienced by the caregivers in various dimensions (e.g., health, psychological well-being, finances, social) of their lives as a result of caregiving. Each item is rated on a Likert scale ranging from 0 (Never) to 4 (Almost always) and indicates how often the caregiver has experienced the described situation. A total score ranging from 0 to 88 is calculated with increasing scores indicating greater burden experienced. | 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). | |
Primary | Change from baseline in the Zarit Caregiver Burden Interview (ZBI) total scores at a 3-week follow up period | Caregiver burden will be assessed using the ZBI. The ZBI is a 22-item self-report questionnaire designed to measure the extent of the burden experienced by the caregivers in various dimensions (e.g., health, psychological well-being, finances, social) of their lives as a result of caregiving. Each item is rated on a Likert scale ranging from 0 (Never) to 4 (Almost always) and indicates how often the caregiver has experienced the described situation. A total score ranging from 0 to 88 is calculated with increasing scores indicating greater burden experienced. | The ZBI will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period. | |
Primary | Change from after the 2-week period in the Zarit Caregiver Burden Interview (ZBI) total scores at a 3-week follow up period | Caregiver burden will be assessed using the ZBI. The ZBI is a 22-item self-report questionnaire designed to measure the extent of the burden experienced by the caregivers in various dimensions (e.g., health, psychological well-being, finances, social) of their lives as a result of caregiving. Each item is rated on a Likert scale ranging from 0 (Never) to 4 (Almost always) and indicates how often the caregiver has experienced the described situation. A total score ranging from 0 to 88 is calculated with increasing scores indicating greater burden experienced. | The ZBI will be administered after a 2-week period and at a 3-week follow-up period. | |
Primary | Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at 2 weeks | 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 in the past four weeks. 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 2-week period). | |
Primary | Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at a 3-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 in the past four weeks. 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 3-week follow-up period. | |
Primary | Change from after a 2-week period on the Perceived Stress Scale-10 (PSS-10) total scores at a 3-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 in the past four weeks. 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 after a 2-week period and at a 3-week follow-up period. | |
Primary | Change from baseline in the Short-Form Health Survey-12 (SF-12) scores at 2 weeks | Overall well-being will be assessed using the SF-12. The SF-12 was derived from the original 30-item scale and is a self-report questionnaire that measures two dimensions of overall health: physical and mental. Accordingly, the scale consists of a Physical Component (SF-PC) and a Mental Component (SF-MC). Each item in the SF-12 is scored according to the scale's scoring algorithm and combined for each subscale. Total and subscale (SF-PC and SF-MC) scores range from 0 to 100, with increasing normed scores indicating better health and a score of 50 is average. | 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). | |
Primary | Change from baseline in the Short-Form Health Survey-12 (SF-12) scores at a 3-week follow up period | Overall well-being will be assessed using the SF-12. The SF-12 was derived from the original 30-item scale and is a self-report questionnaire that measures two dimensions of overall health: physical and mental. Accordingly, the scale consists of a Physical Component (SF-PC) and a Mental Component (SF-MC). Each item in the SF-12 is scored according to the scale's scoring algorithm and combined for each subscale. Total and subscale (SF-PC and SF-MC) scores range from 0 to 100, with increasing normed scores indicating better health and a score of 50 is average. | The SF-12 will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period. | |
Primary | Change from after a 2-week period in the Short-Form Health Survey-12 (SF-12) scores at a 3-week follow up period | Overall well-being will be assessed using the SF-12. The SF-12 was derived from the original 30-item scale and is a self-report questionnaire that measures two dimensions of overall health: physical and mental. Accordingly, the scale consists of a Physical Component (SF-PC) and a Mental Component (SF-MC). Each item in the SF-12 is scored according to the scale's scoring algorithm and combined for each subscale. Total and subscale (SF-PC and SF-MC) scores range from 0 to 100, with increasing normed scores indicating better health and a score of 50 is average. | 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. | |
Primary | Change from baseline in the Dementia Knowledge Assessment Tool Version 2 (DKAT2) total scores at 2 weeks | Knowledge about dementia will be assessed using the DKAT2. DKAT2 is a 21-item self-report questionnaire designed to assess overall knowledge about dementia and dementia care among caregivers and health care staff. The DKAT2 expands from the previous DKAT version (i.e., DKAT1) by including items that are also be pertinent to family members and informal caregivers of people with dementia. Thirteen items in the scale are correct and eight items are incorrect. As such, reversal ratings are required and a score is calculated by summing the total number of correct responses ranging from 0 to 21, with higher scores indicating greater overall knowledge about dementia. | 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). | |
Primary | Change from baseline in the Dementia Knowledge Assessment Tool Version 2 (DKAT2) total scores at a 3-week follow up period | Knowledge about dementia will be assessed using the DKAT2. DKAT2 is a 21-item self-report questionnaire designed to assess overall knowledge about dementia and dementia care among caregivers and health care staff. The DKAT2 expands from the previous DKAT version (i.e., DKAT1) by including items that are also be pertinent to family members and informal caregivers of people with dementia. Thirteen items in the scale are correct and eight items are incorrect. As such, reversal ratings are required and a score is calculated by summing the total number of correct responses ranging from 0 to 21, with higher scores indicating greater overall knowledge about dementia. | The DKAT2 will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period. | |
Primary | 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 | Knowledge about dementia will be assessed using the DKAT2. DKAT2 is a 21-item self-report questionnaire designed to assess overall knowledge about dementia and dementia care among caregivers and health care staff. The DKAT2 expands from the previous DKAT version (i.e., DKAT1) by including items that are also be pertinent to family members and informal caregivers of people with dementia. Thirteen items in the scale are correct and eight items are incorrect. As such, reversal ratings are required and a score is calculated by summing the total number of correct responses ranging from 0 to 21, with higher scores indicating greater overall knowledge about dementia. | 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 | Total System Usability Scale (SUS) score after the 2 week period | Overall app usability will be assessed using the SUS. SUS is a 10-item self-report questionnaire designed to efficiently assess the usability of a technology or product. Each item is rated on a Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). An adjustment rating is needed to account for alternating positive and negative tone items in the instrument. Accordingly, 1 point is subtracted from the raw score of the odd-numbered items, while the raw score of even-numbered items is subtracted from 5. Next, the adjusted scores are added and multiplied by 2.5 to get the standard SUS score. A total score ranging from 5 to 100 is calculated with increasing scores indicating greater agreement and technology usability. | The SUS will be administered after the end of the intervention period (i.e., after a 2 week period) for app-using participants. | |
Secondary | Total Mobile App Rating Scale Subjective App Quality score after the 2 week period | The subjective quality section of the MARS will be used to assess the user's overall app satisfaction. MARS is a 23-item questionnaire designed to assess the quality of mHealth applications. Each item is rated on a Likert scale ranging from 1 (inadequate) to 5 (excellent). The questionnaire includes a 4-item app quality section. A total score is obtained by summing the scores for each item and ranges from 1 to 20, with higher scores indicating greater user quality rating and satisfaction. The four items in the scale assess user's likeliness to recommend/pay for app, extent to which the app stimulates repeated use, and overall app satisfaction. | 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. |
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