Telehealth Intervention for Dementia

Overseen By Celeste Roberts, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Elizabeth K Rhodus

Must not be taking: Antipsychotics

Disqualifiers: Unstable medical conditions, Major depression, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a telehealth program called Harmony at HOME to determine if it can improve the well-being and functioning of people with Alzheimer's and other types of dementia. The program uses video calls to connect participants and their caregivers with occupational therapists. Another group will have sessions focused on caregiver education materials. This trial suits individuals living at home with a stable condition who have experienced recent behavior challenges and have a caregiver willing to participate. As an unphased trial, it offers a unique opportunity to explore innovative care solutions and enhance quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on psychotropic medication, your dosage and treatment should be stable for the duration of the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Harmony at HOME, a telehealth occupational therapy program, is safe for people with Alzheimer's disease and similar conditions. Earlier studies examined the program's practicality and found that participants managed it well. No serious side effects occurred, indicating that the program is safe for home use. This non-drug approach aims to improve behavior and daily activities without the side effects associated with medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Harmony at HOME telehealth intervention for dementia because it offers a new way to support patients and caregivers right in their homes. Unlike traditional treatments that often require in-person visits or medication, Harmony at HOME provides remote access to resources and guidance, which can be especially beneficial for those with mobility challenges or who live far from healthcare facilities. This approach could enhance the quality of life for both patients and caregivers by making care more accessible and personalized.

What evidence suggests that this trial's treatments could be effective for dementia?

Research shows that the "Harmony at HOME" telehealth program, which participants in this trial may receive, can help people with Alzheimer's and similar conditions. In earlier studies, participants showed significant improvements in daily activities and behavior. For example, one study found that people improved in performing everyday tasks. This program uses environmental reminders to support both people with dementia and their caregivers, leading to better outcomes. Overall, these early findings suggest that "Harmony at HOME" could effectively manage behavior issues in dementia patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Elizabeth Rhodus, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for pairs of individuals where one person has dementia (aged 65-99, living at home with a caregiver, and experiencing behavioral challenges) and the other is their caregiver (aged 21-99). Caregivers must be able to communicate in English and handle mail. People can't join if they have severe cognitive impairments themselves or are caring for someone who's very physically ill or violent.

Inclusion Criteria

I am 65-99 with dementia, live at home, have a caregiver, and face behavioral challenges.

I am a caregiver for someone with dementia, aged 21-99, speak English, and can handle mail.

Exclusion Criteria

Participants with Dementia: Unstable medical conditions within one month prior to screening visit, wheelchair or bed bound, residence in skilled nursing facility, physically violent behaviors reported by caregiver, recent initiation of antipsychotic medication, diagnosis of profound sensory altering disorders, major depression or mental illness in past 12 months, major infection within 4 weeks prior to Baseline Visit.

I am caring for someone with mild cognitive impairment or dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week telehealth occupational therapy intervention or an active control with caregiver education sessions

8 weeks

8 telehealth sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Harmony at HOME
• National Institute on Aging Program

Trial Overview The study tests an 8-week telehealth occupational therapy program called Harmony at HOME against a control group receiving general caregiver education via Zoom. It aims to see if this intervention helps reduce dementia symptoms and improve daily function.

How Is the Trial Designed?

Group I: Harmony at HOME Experimental Treatment 1 Intervention

Participants in this group will receive the Harmony at HOME intervention.

Group II: National Institute on Aging Program Active Control 1 Intervention

Participants in this group will receive the National Institute on Aging education.

Who Is Running the Clinical Trial?

Elizabeth K Rhodus

Lead Sponsor

Trials

4

Recruited

190+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Telehealth interventions significantly reduced depression levels in 1379 individuals with dementia, with a strong effect size (SMD -0.63), indicating their potential effectiveness in managing mental health in this population.

Caregivers also reported improved perceived competency (SMD 0.27), suggesting that telehealth can enhance their confidence in providing care, although no significant effects were found on cognitive function or quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of telehealth intervention for people with dementia and their carers: A systematic review and meta-analysis of randomized controlled studies. Saragih, ID., Tonapa, SI., Porta, CM., et al.[2022]

A study involving 120 elderly dementia patients showed that both massage therapy and ear acupuncture significantly improved behavior, sleep disturbances, and participation in rehabilitation and eating over a three-month period.

The positive effects of these treatments were not only significant during the intervention but also persisted for two months after the treatment ended, indicating lasting benefits for dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ear therapy and massage therapy in the elderly with dementia: a pilot study. Rodríguez-Mansilla, J., González-López-Arza, MV., Varela-Donoso, E., et al.[2019]

This systematic review will evaluate the efficacy and safety of non-pharmacological interventions for dementia by analyzing randomized controlled trials, ensuring a rigorous assessment of the available evidence.

The review aims to provide a comprehensive understanding of current non-pharmacological treatments for dementia, which will serve as a foundation for future clinical research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-pharmacological interventions for patients with dementia: A protocol for a systematic review and meta-analysis. Lee, GE., Kim, JY., Jung, JH., et al.[2023]

A 6-month multimodal, nondrug therapy (motor stimulation, activities of daily living, and cognitive stimulation) significantly improved overall dementia symptoms in 130 nursing home residents with degenerative dementia, particularly enhancing social behavior and instrumental activities of daily living.

The intervention did not affect functional independence or total care time, suggesting that while it can alleviate some symptoms of dementia, it may not reduce the overall care needs of these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of multimodal nondrug therapy on dementia symptoms and need for care in nursing home residents with degenerative dementia: a randomized-controlled study with 6-month follow-up. Luttenberger, K., Donath, C., Uter, W., et al.[2022]

Occupational therapy specifically designed for individuals with moderate to severe dementia has been shown to effectively improve quality of life and maintain mental capacity and independence in daily activities.

This type of therapy can be more cost-effective than traditional medical treatments, as it helps reduce nursing care costs associated with dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of occupational therapy for persons with moderate and severe dementia. Korczak, D., Habermann, C., Braz, S.[2022]

Occupational Therapy (OT) interventions significantly help reduce caregiver burden, depression, and stress among caregivers of people with dementia, particularly through home-based programs.

The most frequently utilized OT intervention was the Tailored Activity Program (TAP), specifically designed for caregivers of individuals with Alzheimer's disease, highlighting its effectiveness in improving caregivers' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational Therapy Interventions for Dementia Caregivers: Scoping Review. Martínez-Campos, A., Compañ-Gabucio, LM., Torres-Collado, L., et al.[2023]

Occupational therapy (OT) can effectively help maintain cognitive function and reduce behavioral issues in dementia patients, as shown in a study of 421 patients over a 6-month period.

Patients with mild dementia stages, particularly those with lower education levels and higher cognitive function, experienced greater benefits from OT, suggesting targeted approaches may enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of Occupational Therapy in Dementia Patients: Findings from a Real-World Observational Study. Pimouguet, C., Le Goff, M., Wittwer, J., et al.[2022]

Non-pharmacological interventions (NPI) significantly improved activities of daily living (ADL) and reduced depression in people with moderate to severe dementia, based on a meta-analysis of 10 randomized controlled trials.

While NPI did not effectively reduce agitation, anxiety, or improve cognitive function, music therapy specifically showed promise in reducing overall behavioral and psychological symptoms of dementia (BPSD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-Analysis of Nonpharmacological Interventions for Moderate to Severe Dementia. Na, R., Yang, JH., Yeom, Y., et al.[2020]

Occupational therapy delivered through telehealth can potentially reduce caregiver burden for individuals with dementia by focusing on home modifications and safety, but there is currently limited evidence supporting its effectiveness.

Participants in the study expressed a need for more awareness and understanding of occupational therapy's role in dementia care, highlighting the importance of further research into telehealth as a viable method for delivering these services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persons With Dementia and Their Caregivers' Perceptions About Occupational Therapy and Telehealth: A Qualitative Descriptive Study. Nissen, RM., Hersch, G., Tietze, M., et al.[2019]

A telehealth program involving systematic physical and cognitive exercises for older adults with dementia showed potential to improve their functional capacity, mental health, and quality of life, as evaluated over a 12-week period with 78 participants.

This approach offers a viable alternative for home care during the COVID-19 pandemic, potentially reducing the strain on health resources while maintaining engagement and support for both patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of telehealth on functional capacity, mental health and quality of life among older people with dementia: LAPESI telehealth protocol for a randomized controlled trial. Tsen, C., Andreatto, CAA., Aily, JB., et al.[2023]

The TeleFAMILIES telehealth intervention significantly reduced caregiver burden and depressive symptoms among 216 caregivers of persons with dementia, with notable improvements in scores on the Zarit Burden Interview and Center for Epidemiologic Studies Depression Scale.

Caregivers using the TeleFAMILIES program experienced greater improvements in managing behavioral symptoms of dementia compared to those receiving in-person support, highlighting the effectiveness and convenience of telehealth services in caregiver support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy of TeleFAMILIES: a telehealth intervention for caregivers of community-dwelling people with dementia. Rice, JD., Sperling, SA., Brown, DS., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12230769/

Creating harmony at home via environmental cueing There were statistically significant improvements in functional performance of the person living with dementia (p < 0.005) and caregivers' ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05202223

Harmony at Home: A Pilot Telehealth Program for Rural ... Creating harmony at home via environmental cueing: A feasibility trial of a non-pharmacological intervention for rural caregivers of persons with dementia.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10494967/

Feasibility of Telehealth Occupational Therapy for Behavioral ... This study assesses the feasibility of HARMONY (Helping older Adults cReate & Manage OccupatioNs successfully), a novel occupational therapy ...

4. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.062294

Harmony at HOME (Help Online Modifying the Environment ... This study aimed to assess feasibility of Harmony at HOME (Help Online Modifying the Environment), a telehealth occupational therapy intervention for community ...

5. scholars.uky.edu scholars.uky.edu/en/publications/harmony-at-home-help-online-modifying-the-environment-proof-of-co

Harmony at HOME (Help Online Modifying the Environment) This study aimed to assess feasibility of Harmony at HOME (Help Online Modifying the Environment), a telehealth occupational therapy intervention for community ...

6. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.70405

Creating harmony at home via environmental cueing: A ... Harmony at HOME (Help Online Modifying the Environment) is an innovative intervention that promotes PE-fit by providing knowledge and skills ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40621818/

Creating harmony at home via environmental cueing - PubMed Creating harmony at home via environmental cueing: A feasibility trial of a non-pharmacological intervention for rural caregivers of persons with dementia.