What side effects are associated with this type of intervention?

Common treatments for dementia, such as cholinesterase inhibitors (e.g., donepezil, galantamine) and memantine, have several known side effects. Cholinesterase inhibitors often cause gastrointestinal issues like nausea, vomiting, and diarrhea, as well as muscle cramps and insomnia. Memantine is generally better tolerated but can lead to dizziness, headache, confusion, and constipation. Antipsychotics, sometimes used for managing neuropsychiatric symptoms, can cause sedation, increased risk of falls, and metabolic changes. These side effects can impact both patients and caregivers, emphasizing the need for careful management and monitoring.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of dementia, particularly Alzheimer's disease. These include acetylcholinesterase inhibitors such as donepezil (Aricept) and rivastigmine (Exelon), which aim to slow cognitive decline. Memantine (Namenda), an NMDA receptor antagonist, is also approved for moderate to severe Alzheimer's disease. These medications focus on symptomatic relief rather than disease modification. The CuRB-IT trial, which emphasizes caregiver stress reduction and coping enhancement, does not directly align with these pharmacological treatments but highlights the importance of comprehensive care approaches in dementia management.

What other types of research exist?

Promising alternatives to CuRB-IT for dementia patients include: 1) Memantine, which has shown potential in various studies for managing symptoms of dementia. 2) Cholinesterase inhibitors like donepezil and rivastigmine, which have been effective in improving cognitive function. 3) Non-pharmacological interventions such as cognitive behavioral therapy (CBT) for caregivers, which can help manage stress and improve coping mechanisms. 4) Mindfulness-based stress reduction programs, which have shown benefits in reducing caregiver stress and improving quality of life.

← Back to Search

Caregiver Coaching for Dementia (CuRB-IT Trial)

N/A

Recruiting

Led By Rita A Jablonski, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The care provided consists of help with at least 2 Instrumental Activities of Daily Living or one Activity of Daily Living

Be older than 18 years old

Must not have

Persons who cannot speak/read English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up daily during weeks 49, 50, and 51

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an online training program called CuRB-IT, which helps family caregivers of people with dementia manage difficult behaviors. The program aims to boost caregivers' confidence and provide practical coping methods, making caregiving less stressful.

Who is the study for?

This trial is for family caregivers over 18 years old who help a relative with mild cognitive impairment or dementia and face resistance when providing care. Caregivers must speak/read English, have internet access, and share living or cooking space with the care recipient.

What is being tested?

The study tests CuRB-IT, an intervention for caregivers dealing with care-resistant behavior in dementia patients. Participants are split into two groups: one starts CuRB-IT immediately and the other after a delay, both completing surveys and diaries to track progress.

What are the potential side effects?

Since this trial involves coaching rather than medication, there aren't typical drug side effects. However, participants may experience emotional distress or fatigue from discussing caregiving challenges.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need help with daily tasks like dressing or using the bathroom.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot speak or read English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ daily during weeks 49, 50, and 51

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~daily during weeks 49, 50, and 51

This trial's timeline: 3 weeks for screening, Varies for treatment, and daily during weeks 49, 50, and 51 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dementia

Change in caregiver self-efficacy coping skills

Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Immediate InterventionExperimental Treatment1 Intervention

Complete baseline survey, complete 3 weeks of daily diaries and intermittent survey, receive 12 weeks of CurB-IT, then complete 3 rounds of 21-day daily diaries and intermittent surveys while receiving attention during the 12-week intervals between daily diaries.

Group II: Delayed interventionActive Control1 Intervention

Complete baseline survey, complete 3 weeks of daily diaries, receive 12 weeks of attention, complete 3 weeks of daily diaries and 1 intermittent survey, receive 12 weeks of CurB-IT, then complete 2 rounds of 21-day daily diaries and intermittent surveys while receiving attention during the 12-week intervals between daily diaries.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for dementia include pharmacologic approaches like cholinesterase inhibitors (e.g., donepezil) and NMDA receptor antagonists (e.g., memantine), which work by enhancing neurotransmitter function and slowing cognitive decline. Nonpharmacologic treatments, such as caregiver support programs like CuRB-IT, focus on reducing caregiver stress and enhancing coping strategies. These interventions are crucial as they improve the caregiving environment, potentially leading to better patient outcomes and reduced caregiver burnout.

Enhanced rehabilitation and care models for adults with dementia following hip fracture surgery.Recruiting Dementia Caregivers Into Clinical Trials: Lessons Learnt From the Australian TRANSCENDENT Trial.