Stress Management Toolkit for Dementia

Overseen By Susan N Hastings, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Duke University

Disqualifiers: Hearing impairment, Visual impairment, Cytokine therapy, Radiation therapy, Cushing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

44 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to develop a prototype of a home-based, dyadic tangible toolkit comprised of simple tools to help people living with dementia (PLWD) and their care partners manage stress at home. A human-centered design approach will be used to develop and user-test a prototype of a dyadic, tangible stress-management toolkit with and for PLWD and their care partners; and to explore the feasibility of collecting several stress-related outcomes. A total of 4 focus groups (n=3-4 dyads/group) will be convened to explore the experiences, perceptions, preferences, and recommendations of dementia-caring dyads regarding stress, stress management, and key components and features of a stress management toolkit. Eligible tools for the toolkit include low burden, high safety tools such as weighted blankets, robotic pets and baby dolls, guided journals, aromatherapy and bright light therapy devices, and massage and acupressure tools. Ten dyads who were not involved in prototype development will then use the toolkit for 2 weeks. Feedback on usability, feasibility, and acceptability will be collected through questionnaires (end of weeks 1 and 2) and 3 focus groups (3-4 dyads/group at end of week 2). We will collect stress-related, participant-reported outcomes (e.g., neuropsychiatric symptoms of dementia, caregiver stress, dyadic relationship strain), and saliva biospecimens from participants with dementia and their care partners at baseline and end of week 2, to explore their utility as endpoints in a future toolkit intervention that uses a single-arm, pre-post study design. Results will yield valuable data to support development and preliminary testing of a stress management toolkit intervention in a future pilot study. This study involves human subjects and is expected to yield no more than minimal risk. Tools eligible for the toolkit must have demonstrated high degrees of safety in prior research. Major risks for participation include the potential for negative emotional responses to focus group discussions and surveys pertaining to stress, excess time burden to participate in the study, and breach of confidentiality. It is not anticipated, but there is a potential for physical discomfort if tools are not used as directed, which is why the toolkits will include a user guide outlining safety information, which a research team member will review with each participant prior to use.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you are currently receiving cytokine-based therapy or radiation therapy to the salivary glands or thyroid, or if you have Cushing or Addison's disease.

What data supports the idea that Stress Management Toolkit for Dementia is an effective treatment?

The available research shows that the Stress Management Toolkit for Dementia, which includes tools like animatronic pets and aromatherapy, is designed to help people with dementia and their caregivers manage stress at home. While the specific data on its effectiveness is not detailed, the concept of using non-drug tools for stress management is promising. Compared to other treatments, such as the psycho-educative group program 'Learning to feel better… and help better,' which has shown success in reducing stress and behavior problems, the Stress Management Toolkit offers a home-based alternative. This could make it more accessible and easier to use for caregivers who cannot attend group sessions. ^{1 2 3 4 5}

What safety data exists for the Stress Management Toolkit for Dementia?

The Stress Management Toolkit for Dementia is designed to be a safe, nonpharmacologic intervention using tools like animatronic social pets, weighted blankets, aromatherapy, and massage tools. The development protocol emphasizes safety and ease of use in a home setting. However, specific safety data from clinical trials or studies directly evaluating this toolkit under its various names is not detailed in the provided research abstracts. ^{1 4 6 7 8}

Is the Stress Management Toolkit a promising treatment for people with dementia and their caregivers?

Yes, the Stress Management Toolkit is a promising treatment because it offers simple, safe, and easy-to-use tools that can be used at home to help manage stress for people with dementia and their caregivers. ^{1 2 4 9 10}

Research Team

Melissa L Harris, PhD

Principal Investigator

Duke University School of Nursing

Susan N Hastings, MD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for people aged 60 and over with any type of dementia who can speak English and express themselves verbally. It's also for their care partners. The study aims to help them manage stress at home using a toolkit.

Inclusion Criteria

Dyadic eligibility criteria: both the PLWD and care partner reside in the same household or personal residence in the community, dyad has lived together for at least 1 month, dyad has telephone or internet access

I am over 60, diagnosed with dementia, can speak for myself, and speak English.

Exclusion Criteria

My care partner has a hearing or visual impairment that affects their participation.

Dyads: reside in assisted living or other long-term care setting

I have dementia and a hearing or visual impairment that affects my participation in studies.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prototype Development

Focus groups are conducted to explore experiences, perceptions, preferences, and recommendations of dementia-caring dyads regarding stress management and toolkit features.

4 weeks

4 focus groups (in-person)

User Testing

Ten dyads use the stress management toolkit at home for 2 weeks. Feedback on usability, feasibility, and acceptability is collected through questionnaires and focus groups.

2 weeks

3 focus groups (in-person) and questionnaires at end of weeks 1 and 2

Follow-up

Participants are monitored for stress-related outcomes and toolkit effectiveness after the user testing phase.

1 week

Treatment Details

Interventions

• Stress Management Toolkit

Trial Overview The trial is testing a stress management toolkit designed specifically for those living with dementia and their caregivers. Participants will use tools like weighted blankets, robotic pets, journals, aromatherapy devices, etc., and provide feedback on the experience.

Participant Groups

Group I: Stress Management Toolkit Prototype User Testing Experimental Treatment 1 Intervention

10 dyads will use the toolkit for 2 weeks in their own homes. Feedback on usability, feasibility, and acceptability will be collected through questionnaires and focus groups. Stress-related, participant-reported outcomes (e.g., neuropsychiatric symptoms of dementia, caregiver stress, dyadic relationship strain), and salivary cortisol biospecimens will be collected at baseline and end of week 2, to explore their utility as endpoints in a future pilot study to examine efficacy.

Group II: Stress Management Toolkit Prototype Development Active Control 1 Intervention

3-4 qualitative focus groups (n=3-4 dyads/group) will be held to explore experiences, perceptions, preferences, and recommendations of dementia-caring dyads regarding stress, stress management, and key components and features of a stress management toolkit. Eligible tools for the toolkit include low burden, high safety tools (e.g., weighted blankets, robotic pets and baby dolls, guided journals, aromatherapy, bright light therapy devices, massage and acupressure tools).

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

The study aims to develop and test a user-friendly stress management toolkit for people living with dementia and their care partners, using simple, nonpharmacologic tools like animatronic pets and aromatherapy, to help manage stress effectively.

By employing a human-centered design approach and involving dementia caring dyads in the co-design process, the intervention is expected to be more acceptable and feasible for real-world use, with preliminary data supporting its potential for implementation in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Home-Based Stress Management Toolkit for Dementia Caring Dyads: Protocol for a Pilot Intervention Development and Feasibility Study. Harris, M., Van Houtven, C., Hastings, S.[2022]

The program 'Learning to feel better… and help better' was successfully implemented in French-speaking Switzerland, showing high acceptance and strong participant engagement among informal caregivers of persons with dementia.

Participants experienced significant improvements in caregiver burden, psychological distress, and self-efficacy, indicating that the intervention effectively helps caregivers manage stress and apply learned coping strategies in their daily lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping with dementia caregiving: a mixed-methods study on feasibility and benefits of a psycho-educative group program. Pihet, S., Kipfer, S.[2019]

In a study of 213 caregivers, the most significant predictors of distress varied by caregiver type: for spouses, it was the impact on health and schedule, while for adult children living with the patient, it was primarily the impact on health.

Adult children not living with the person with dementia experienced distress related to health, schedule, and finances, highlighting the need for tailored support strategies for different caregiver profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of caregiver distress among spouses, adult children living with the person with dementia, and adult children not living with the person with dementia. Wawrziczny, E., Duprez, C., Antoine, P.[2021]

The iCare Stress Management e-Training Program significantly reduced perceived stress among dementia family caregivers compared to an Education/Information-Only condition, indicating its potential efficacy in stress management.

Despite the positive results, the study faced a high dropout rate of about one-third of participants, highlighting the need for strategies to enhance engagement and retention in future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the effectiveness of an internet-based program for reducing caregiver distress using the iCare Stress Management e-Training Program. Kajiyama, B., Thompson, LW., Eto-Iwase, T., et al.[2022]

An educational intervention based on the Progressively Lowered Stress Threshold (PLST) model significantly improved the knowledge and caregiving practices of 38 caregivers for people with dementia over a two-year period in Isfahan, Iran.

The study demonstrated that tailored educational content, considering cultural and religious backgrounds, effectively enhanced caregivers' skills in managing challenging behaviors associated with dementia, as indicated by statistically significant increases in their knowledge and practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of educational intervention based on the Progressively Lowered Stress Threshold extended model on the process of caregiving for people with dementia. Zamani-Alavijeh, F., Zahed, S., Emami, M., et al.[2023]

A systematic review of 24 studies on dyadic psychoeducational support programs for people with dementia and their caregivers found that tailored, goal-oriented programs significantly improve various aspects of health and quality of life for both parties.

The review highlights the importance of long-term, individualized support programs to address the progressive needs of individuals with dementia and their caregivers, suggesting that such interventions can lead to sustained positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of dyadic psychoeducational programs for persons with dementia and their family caregivers. Ghosh, M., Dunham, M., O'Connell, B.[2023]

A randomized controlled trial involving 111 dyads of people with dementia and their caregivers tested a multi-component intervention but found no significant benefits on caregivers' mood, burden, or health outcomes over time.

The lack of effectiveness may be due to changes made in the intervention's design, such as its shortening and the exclusion of cognitive reframing, highlighting the importance of tailoring interventions to the specific needs and contexts of participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a multi-component dyadic intervention on the psychological distress of family caregivers providing care to people with dementia: a randomized controlled trial. Prick, AE., de Lange, J., Twisk, J., et al.[2022]

An 8-week mindfulness-based stress reduction (MBSR) training course significantly improved psychological resilience in non-professional caregivers of Alzheimer's patients, indicating its potential as an effective intervention for caregiver stress.

The study identified specific biomarkers in blood that predict which caregivers are likely to benefit from MBSR, providing insights into the mechanisms behind its health benefits and paving the way for personalized approaches in caregiver support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomarkers of Resilience in Stress Reduction for Caregivers of Alzheimer's Patients. Ho, L., Bloom, PA., Vega, JG., et al.[2021]

The Baycrest Quick-Response Caregiver ToolTM (BQRCT) was found to be highly feasible and helpful for 21 family caregivers managing neuropsychiatric symptoms of dementia, allowing them to effectively recognize and manage their emotions in real time.

Healthcare providers also found the tool useful, with most recommending it to others, highlighting its potential as a valuable online resource for caregivers who may struggle to access in-person support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Instrument for Caregivers in Managing Neuropsychiatric Symptoms of Dementia: Baycrest Quick-Response Caregiver ToolTM. Madan, R., Natadiria, M., Berall, A., et al.[2022]

A music intervention for people with dementia and their family caregivers led to significantly lower morning cortisol levels in caregivers, indicating reduced stress levels after 8 weeks of the program.

The study involved 34 participants (24 in the intervention group and 10 in the control group) who provided saliva samples to measure stress biomarkers, demonstrating the potential of using such biomarkers to assess the effectiveness of interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing stress using repeated saliva concentration of steroid hormones in dementia care dyads: results from a controlled pilot care music intervention. Emami, A., Theorell, T., Kim, H., et al.[2023]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Development of a Home-Based Stress Management Toolkit for Dementia Caring Dyads: Protocol for a Pilot Intervention Development and Feasibility Study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Coping with dementia caregiving: a mixed-methods study on feasibility and benefits of a psycho-educative group program. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Predictors of caregiver distress among spouses, adult children living with the person with dementia, and adult children not living with the person with dementia. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Exploring the effectiveness of an internet-based program for reducing caregiver distress using the iCare Stress Management e-Training Program. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The effect of educational intervention based on the Progressively Lowered Stress Threshold extended model on the process of caregiving for people with dementia. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Systematic review of dyadic psychoeducational programs for persons with dementia and their family caregivers. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The effects of a multi-component dyadic intervention on the psychological distress of family caregivers providing care to people with dementia: a randomized controlled trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Biomarkers of Resilience in Stress Reduction for Caregivers of Alzheimer's Patients. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

A Novel Instrument for Caregivers in Managing Neuropsychiatric Symptoms of Dementia: Baycrest Quick-Response Caregiver ToolTM. [2022]

10. Sweden pubmed.ncbi.nlm.nih.gov

Assessing stress using repeated saliva concentration of steroid hormones in dementia care dyads: results from a controlled pilot care music intervention. [2023]