Caregiver Support Training for Dementia

(LST Trial)

Overseen By Patricia N Burant, Ed.D., M.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Must not be taking: Antidepressants

Disqualifiers: Non-English speakers, Prior LST participants, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help family caregivers of individuals with Alzheimer's or related dementias improve caregiving skills and reduce stress. Participants will either learn complex care skills through the Learning Skills Together Intervention or focus on healthy living habits with the Caregiver Healthy Living Intervention. The goal is to boost caregivers' confidence and reduce feelings of depression and stress related to dementia symptoms. This trial suits family members who assist with daily activities and have internet access for online sessions. As an unphased trial, it offers caregivers a unique opportunity to enhance their skills and well-being without the constraints of traditional clinical trial phases.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have started or changed depression treatment in the last 3 months, you may not be eligible to participate.

What prior data suggests that this psychoeducational intervention is safe for caregivers?

Research shows that the "Learning Skills Together" (LST) program helps family caregivers manage the complex tasks of caring for someone with dementia. Caregivers who participated in this training felt more confident and prepared for their roles. No safety concerns or negative effects have been reported, as the program provides educational support rather than medication or medical procedures.

Similarly, the "Caregiver Healthy Living" program supports caregivers' overall well-being. Research indicates no safety issues because it focuses on lifestyle improvements. Both programs are educational and supportive, making them easy for participants to handle. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Caregiver Support Training for Dementia because it offers unique approaches to support family caregivers. The Learning Skills Together Intervention stands out by providing complex psychoeducation training that equips caregivers with practical skills to manage caregiving challenges effectively. Meanwhile, the Caregiver Healthy Living Intervention emphasizes a holistic approach, focusing on improving the overall well-being of caregivers through healthy living practices. Both interventions aim to alleviate the emotional and physical burdens on caregivers, potentially enhancing their quality of life, which is a fresh perspective compared to traditional support services that often center solely on patient care.

What evidence suggests that this trial's interventions could be effective for reducing caregiver depression and negative appraisal of dementia symptoms?

Research shows that the Learning Skills Together (LST) program, one of the interventions in this trial, helps family caregivers feel more confident and capable when handling complex care tasks. Studies have found that LST reduces feelings of depression in caregivers and helps them view the behavioral symptoms of dementia more positively. This suggests that LST could make caring for someone with Alzheimer's or related dementias less stressful.

The Caregiver Healthy Living Intervention, another intervention tested in this trial, focuses on promoting healthy lifestyle choices. Research has shown that health education programs like this improve the caregiving experience for families dealing with dementia by helping caregivers take better care of their own well-being. Both interventions aim to support caregivers in different but complementary ways. ^{1 3 4 6 7}

Who Is on the Research Team?

Kylie N Meyer, PhD, Mac

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for adults who help care for a family member with Alzheimer's or related dementia, can attend most online sessions, and assist with daily living tasks. They must speak English, have not recently altered depression treatment, and don't plan to move the care recipient to a nursing facility soon.

Inclusion Criteria

I am a family member of someone diagnosed with Alzheimer's or related dementia.

Report a Global Deterioration Scale (GDS) rating for care recipients between 4 to 6

Commit to attending at least 5 of the 6 discussion sessions

Exclusion Criteria

Participated in Learning Skills Together in the past

Plans to place the care recipient in a skilled nursing facility within the next 9 months (i.e., study duration)

I was diagnosed with depression or changed my depression treatment in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-week psychoeducational intervention focused on complex care tasks for family caregivers

6 weeks

Follow-up

Participants are monitored for changes in caregiver self-efficacy, depression, and appraisal of behavioral symptoms of dementia

6 months

3 visits (virtual) at 2 weeks, 3 months, and 6 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Caregiver Healthy Living Intervention
• Learning Skills Together Intervention

Trial Overview The study tests Learning Skills Together (LST), a program designed to reduce caregiver depression by improving their ability to manage complex caregiving tasks. Participants will either receive LST or join a control group focusing on caregivers' health, comparing outcomes via surveys.

How Is the Trial Designed?

Group I: Learning Skills Together Intervention Experimental Treatment 1 Intervention

Complex care psychoeducation training intervention for family caregivers

Group II: Caregiver Healthy Living Intervention Active Control 1 Intervention

Healthy living intervention for family caregivers

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Training programs for family caregivers of people with dementia typically consist of six sessions over six weeks, focusing on essential skills and strategies for effective care, which can significantly enhance caregiver support.

The review highlights the importance of assessing caregiver needs at three key points during the training (initial, final, and follow-up), which can help tailor support and improve caregiver well-being and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training programmes for family caregivers of people with dementia living at home: integrative review. Sousa, L., Sequeira, C., Ferré-Grau, C., et al.[2018]

In a study involving 43 caregiver and person-with-dementia dyads, active psychoeducational interventions significantly improved caregivers' skills and reduced their burden compared to passive interventions, as measured by various assessment tools.

The active intervention led to better outcomes in caregiver competence and distress levels after just three months, highlighting the effectiveness of engaging methods like role-play and problem-solving in caregiver training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver active participation in psychoeducational intervention improved caregiving skills and competency. Tang, SH., Chio, OI., Chang, LH., et al.[2019]

The Home Safety Toolkit (HST) significantly improved caregiver competence in creating safer home environments for individuals with dementia, as evidenced by reduced caregiver strain and increased self-efficacy, with results showing statistical significance (P ≤ 0.001 for home safety and P = 0.002 for self-efficacy).

The intervention also led to a notable decrease in risky behaviors and accidents among care receivers, highlighting the effectiveness of the HST in enhancing safety for individuals with dementia living at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trial of a home safety toolkit for Alzheimer's disease. Horvath, KJ., Trudeau, SA., Rudolph, JL., et al.[2021]

The psychoeducational program 'Living together with dementia' significantly reduced the burden experienced by family caregivers of people with dementia, based on a quasi-experimental study involving 15 participants.

The study included pretest and posttest assessments with a follow-up period of 4 months, suggesting that the program could be an effective training tool for caregivers in managing dementia-related challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Living Together with Dementia"-A psychoeducational group programme for family caregivers. Sousa, L., Sequeira, C., Ferré-Grau, C., et al.[2022]

Caregiver skill-building interventions for family caregivers of elderly individuals, particularly those caring for dementia patients, are more effective than traditional information and support interventions.

The study identifies essential content and skills that caregivers need to manage difficult behaviors, daily living activities, and cognitive decline in their care recipients, highlighting the importance of targeted training for effective caregiving.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alzheimer's disease caregiving information and skills. Part I: care recipient issues and concerns. Farran, CJ., Loukissa, D., Perraud, S., et al.[2007]

The Minnesota Family Workshop, consisting of seven weekly sessions, effectively reduced caregiver burden for families of dementia patients by providing education, support, and skills training.

The program's design encouraged family involvement by requiring primary caregivers to bring at least one other family member, enhancing the support network for both caregivers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training family caregivers of patients with dementia. A structured workshop approach. Ostwald, SK., Hepburn, KW., Burns, T.[2019]

The study outlines a randomized control trial designed to evaluate the effectiveness of a 7-week training program called 'Living together with Dementia' for family caregivers of individuals with early to moderate dementia, aiming to empower caregivers and improve their skills.

Caregivers will be assessed at three different points: before the training, immediately after, and 3 to 6 months later, using various scales to measure caregiver burden and satisfaction, highlighting the program's potential to enhance caregiver support and intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Living together with dementia": Training programme for family caregivers - A study protocol. Sousa, L., Sequeira, C., Ferré-Grau, C., et al.[2022]

A pilot study involving 35 family caregivers showed that the 4-week Learning Skills Together (LST) psychoeducation program significantly improved caregivers' self-efficacy in providing complex care tasks for persons living with dementia, with measurable improvements at both 4 and 8 weeks post-intervention.

Despite 53% of caregivers providing complex care without training, the LST program was well-received, with participants reporting high satisfaction and finding the information easy to understand, indicating its potential effectiveness in enhancing caregiver confidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver self-efficacy improves following complex care training: Results from the Learning Skills Together pilot study. Meyer, K., Glassner, A., Norman, R., et al.[2023]

Participants in the Paired PLIÉ program reported significant improvements in physical, cognitive, and social/emotional functioning, as well as enhanced relationship quality, highlighting the program's efficacy for people with dementia and their care partners.

Feedback from care partners indicated that transitioning to community classes after the initial program continued to provide benefits, suggesting the program's lasting positive impact on maintaining function and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrative group movement program for people with dementia and care partners together (Paired PLIÉ): initial process evaluation. Casey, JJ., Harrison, KL., Ventura, MI., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05846984

NCT05846984 | Learning Skills Together Family Caregiver ... This study aims to test the efficacy of LST at reducing caregiver depression and negative appraisal of behavioral symptoms of dementia by building caregiver ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38851719/

A randomised controlled trial of the Learning Skills Together ... If efficacious, the LST intervention will support family caregivers in preserving their own mental health while providing complex care. Trial ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08204-8

A randomised controlled trial of the Learning Skills Together ... The primary objective of this study is to determine whether participation in the LST intervention: (1) improves caregiver self-efficacy (primary ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/572055

Learning Skills Together Family Caregiver Complex ... This study aims to test the efficacy of LST at reducing caregiver depression and negative appraisal of behavioral symptoms of dementia by ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0883941724000633

Effectiveness of a health education program for people with ... This study assesses the effectiveness of a health education program on caregiving outcomes for people with dementia and their families.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11161926/

A randomised controlled trial of the Learning Skills ... We developed Learning Skills Together (LST), a 6-week digitally delivered psychoeducational program, to facilitate family caregiver abilities to administer ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/572055

Learning Skills Together Family Caregiver Complex ... This study aims to test the efficacy of LST at reducing caregiver depression and negative appraisal of behavioral symptoms of dementia by ...