CLINICAL TRIAL

Dementia Talk mobile application for Stress (Psychology)

Recruiting · 18+ · All Sexes · Regina, Canada

Evaluation of Mobile Apps for Informal Caregivers of People Living With Dementia

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About the trial for Stress (Psychology)

Eligible Conditions
Stress (Psychology) · Dementia · Caregiver Burden

Treatment Groups

This trial involves 2 different treatments. Dementia Talk Mobile Application is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
CLEAR Dementia Care mobile application
OTHER
Experimental Group 2
Dementia Talk mobile application
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You are providing informal care for a person living with dementia.\n show original
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)
You provide unpaid care to a person who is not a member of your family. show original
own a smartphone (i.e., an iPhone or Android and/or can access either IOS or Android platforms)
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 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.
Screening: ~3 weeks
Treatment: Varies
Reporting: 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.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 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..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Dementia Talk mobile application will improve 12 primary outcomes and 2 secondary outcomes in patients with Stress (Psychology). Measurement will happen over the course of 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)..

Change from baseline in the Zarit Caregiver Burden Interview (ZBI) total scores at 2 weeks
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).
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).
Total Mobile App Rating Scale Subjective App Quality score after the 2 week period
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.
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.
Total System Usability Scale (SUS) score after the 2 week period
THE SUS WILL BE ADMINISTERED AFTER THE END OF THE INTERVENTION PERIOD (I.E., AFTER A 2 WEEK PERIOD) FOR APP-USING PARTICIPANTS.
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.
Change from baseline in the Zarit Caregiver Burden Interview (ZBI) total scores at a 3-week follow up period
THE ZBI WILL BE ADMINISTERED AT BASELINE (I.E., PRIOR TO STARTING THE STUDY) AND 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.
Change from baseline in the Dementia Knowledge Assessment Tool Version 2 (DKAT2) total scores at 2 weeks
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).
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).
Change from baseline in the Dementia Knowledge Assessment Tool Version 2 (DKAT2) total scores at a 3-week follow up period
THE DKAT2 WILL BE ADMINISTERED AT BASELINE (I.E., PRIOR TO STARTING THE STUDY) AND 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.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can caregiver burden be cured?

Caregiver burden is highly prevalent. As caregiver burden is correlated with quality of life, and the quality of life of people being cared for can be improved by reducing the burden of caregivers, there is a case for targeting caregiver burden, as well as for the treatment of the caregivers themselves.

Anonymous Patient Answer

What are common treatments for caregiver burden?

  • Interventions that target the caregiver, family, and healthcare systems can reduce caregiver burden.\n- Caregiver distress is highly correlated with a care recipient's depressive symptoms.\n- Interventions targeted at caregivers to decrease their stress, stressors, and mood may also be effective to reduce caregiver burden.\n- The best approaches to lowering caregiver burden are interventions that target both the caregiver and the recipient of the care. The most effective interventions to reduce caregiver burden include caregiver coping skills training, problem-solving training, and communication and education.
Anonymous Patient Answer

What are the signs of caregiver burden?

Caregiver symptoms include feelings of burnout, frustration, low self-esteem and grief. Burden can also have a negative impact on health care-seeking behavior, as caregivers' health can deteriorate.

Anonymous Patient Answer

How many people get caregiver burden a year in the United States?

around 3.4 million people in the United States become caregivers of somebody with a disability due to degenerative diseases. Caregiving is the most prevalent form of caring for a loved one with a lifelong disability in the United States, especially in the family home. Caregivers face significant emotional burden, work-related stress and financial burden.

Anonymous Patient Answer

What is caregiver burden?

This burden is experienced as a negative impact on the caregivers themselves as well as the people they are caring for. The experiences of the caregivers indicate that their quality of life is significantly impacted. Most likely this burden is only amplified by the burden of caring for multiple family members in dementia situations.

Anonymous Patient Answer

What causes caregiver burden?

The caregiver burden is extremely high with regard to psychological distress, psychiatric and self-care problems, and social relationships. Caregivers need to receive help in dealing with their burden.

Anonymous Patient Answer

What are the latest developments in dementia talk mobile application for therapeutic use?

Although the use of the Talk Me app for caregiver was not associated with an improvement in the caregiver well-being, it may have helped to reduce stress and caregiver's depressive symptoms. The Talk Me app seemed to improve caregiver's ability of addressing patient's problems and the patient satisfaction.

Anonymous Patient Answer

Does dementia talk mobile application improve quality of life for those with caregiver burden?

Caregivers of those with severe dementia are at greater risk of experiencing burdens. The use of this mobile application can enhance the ability of caregivers to provide adequate care, which will lead to improved quality of life.

Anonymous Patient Answer

Who should consider clinical trials for caregiver burden?

A large proportion of caregivers were not aware about, or willing to participate in clinical trials, which can adversely affect quality of life. Caregivers should be encouraged to participate in and benefit from clinical trials, including those for diabetes.

Anonymous Patient Answer

Have there been any new discoveries for treating caregiver burden?

While many studies have attempted to answer this question, there is still no consensus on the best answer. We must continue to understand more about the caregiving experience and its effect and consequences before recommending any new treatments. In general, there is the issue of balancing caregiver needs with patient-centered care. There are also some unique considerations of cancer patients in this area, like balancing patient/patient interaction with balancing caregiver's responsibilities and needs when it comes to treatment. There is the opportunity to explore whether or not caregiving is positively related to caregiver satisfaction as well as caregiver well-being. It must be noted that while these questions have been addressed, there is still much work to be done in this area.

Anonymous Patient Answer

What are the common side effects of dementia talk mobile application?

Users complained significantly more about the side effects when it was done through the app than when they did so verbally. Recent findings of this study will help to develop the next generation of tools for delivering information to people with dementia.

Anonymous Patient Answer

How does dementia talk mobile application work?

As the prevalence of dementia increases and the demand for technology in healthcare rises, the possibility of a low-cost, low tech intervention to improve healthcare in an ageing population becomes increasingly important. Whilst the evidence base for smartphone applications to support people with dementia is not as strong as with the older population, there is good evidence available that this low-cost population-focused technology can improve the wellbeing of people with dementia.

Anonymous Patient Answer
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