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

76 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the Harmony at HOME telehealth occupational therapy treatment for dementia?

Research shows that occupational therapy can improve the quality of life for people with dementia and reduce the burden on their caregivers. Telehealth, which allows therapy to be delivered remotely, is expanding and has potential for use in dementia care, although more evidence is needed to fully support its effectiveness. ^{1 2 3 4 5}

Is telehealth occupational therapy safe for people with dementia?

There is currently a lack of specific evidence on the safety of telehealth occupational therapy for people with dementia, but non-pharmacological interventions, in general, are being studied for their safety and effectiveness. ^{3 4 6 7 8}

How is the Harmony at HOME telehealth treatment for dementia different from other treatments?

Harmony at HOME is unique because it uses telehealth to deliver occupational therapy (helping with daily activities) to people with dementia and their caregivers, focusing on home modifications and safety, which can reduce caregiver burden. This approach is novel as it leverages technology to provide non-drug support directly in the home, unlike traditional in-person therapy sessions. ^{3 4 9 10 11}

What is the purpose of this trial?

This trial will assess feasibility of a non-pharmacological intervention for persons living with Alzheimer's disease and related dementias (ADRD) to improve behavioral and psychiatric symptoms of dementia and functional performance. Using a two-arm, prospective randomized controlled trial, 38 dyads (person with ADRD and caregiver) will complete an 8-week telehealth occupational therapy intervention provided via Zoom with caregivers and persons with dementia or receive an active control with 8 telehealth sessions to discuss publicly available caregiver education with a non-clinical research assistant.

Research Team

Elizabeth Rhodus, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 (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]

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]

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]

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]

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]

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]

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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Occupational Therapy Interventions for Dementia Caregivers: Scoping Review. [2023]

2. United States 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. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Benefits of Occupational Therapy in Dementia Patients: Findings from a Real-World Observational Study. [2022]

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

Persons With Dementia and Their Caregivers' Perceptions About Occupational Therapy and Telehealth: A Qualitative Descriptive Study. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

The effectiveness of occupational therapy for persons with moderate and severe dementia. [2022]

6. China pubmed.ncbi.nlm.nih.gov

Ear therapy and massage therapy in the elderly with dementia: a pilot study. [2019]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-Analysis of Nonpharmacological Interventions for Moderate to Severe Dementia. [2020]

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

Non-pharmacological interventions for patients with dementia: A protocol for a systematic review and meta-analysis. [2023]

9. United States 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. [2022]

10. United States 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. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy of TeleFAMILIES: a telehealth intervention for caregivers of community-dwelling people with dementia. [2022]