Behavioral Change Techniques for Caregivers of Alzheimer's Disease Patients

Overseen By Mark Butler, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Unsafe walking, No smartphone, No email, others

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help caregivers of individuals with Alzheimer's and related conditions become more active. Personalized text messages encourage caregivers to walk more, aiming for over 250 steps each hour. The trial seeks to determine if these messages, part of the Behavior Change Technique Package, can help at least half of the caregivers develop a regular walking habit. It may suit caregivers who feel they don’t move much and seek ways to increase their activity. As an unphased trial, it offers caregivers a unique opportunity to explore innovative methods to enhance their activity levels.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on increasing physical activity through text-message interventions for caregivers.

What prior data suggests that this behavior change technique is safe for caregivers of Alzheimer's patients?

Research has shown that behavior change techniques (BCTs) are generally safe for caregivers of Alzheimer's patients. Studies have found that methods like setting goals, making action plans, and tracking progress do not pose significant safety risks. These techniques aim to help caregivers build healthy habits, such as increasing physical activity.

While specific data on negative effects from this BCT package is limited, individuals using similar methods have successfully increased their physical activity without major problems. The research available has not reported any harmful side effects.

Overall, BCTs are well-tolerated and focus on positive behavior changes, making them a safe choice for caregivers seeking to improve their health and well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavior Change Technique Package for Alzheimer's caregivers because it offers a personalized approach to supporting those who care for patients with this condition. Unlike standard care options that often focus on medication or general support groups, this treatment uses four specific behavior change techniques daily—Goal Setting, Action Planning, Self-Monitoring, and Prompt/Cue. These techniques are rooted in habit formation theory, aiming to develop sustainable habits that enhance caregivers' well-being and capacity to provide care. This innovative, structured approach could lead to more effective and lasting improvements in caregiver health and patient care.

What evidence suggests that this behavior change technique is effective for increasing physical activity in caregivers of Alzheimer's patients?

Studies have shown that certain techniques can help people develop new habits, such as walking regularly. In this trial, caregivers of Alzheimer's patients will receive a Behavior Change Technique Package, which includes setting goals, planning activities, tracking progress, and using reminders. These methods have been linked to better exercise habits in other contexts. Although evidence is insufficient to confirm improved patient outcomes, these techniques show promise in helping caregivers build healthier routines. Early research suggests these methods could increase caregivers' daily walking. ^{2 3 6 7 8}

Who Is on the Research Team?

Ashley Goodwin, PhD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for caregivers of individuals with Alzheimer's Disease or related dementias who lead a sedentary lifestyle. It aims to help them develop a habit of hourly physical activity, specifically walking more than 250 steps per hour.

Inclusion Criteria

Identify as a caregiver (formal/paid or informal/unpaid) for persons with Alzheimer's Disease or Alzheimer's Disease Related Dementias (AD/ADRD)

Self-report low levels of physical activity or walking

Exclusion Criteria

My doctor says it's unsafe for me to participate in walking activities.

Does not own or cannot regularly access a smartphone capable of receiving text messages or accessing the internet

Does not own or have access to an email address

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a personalized, multi-component BCT intervention to encourage habitual hourly physical activity

12 weeks

Daily text-message interventions

Follow-up

Participants are monitored for habit formation and changes in automaticity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavior Change Technique Package

Trial Overview The study is testing a personalized text-message delivered behavior change technique (BCT) intervention over 12 weeks. The goal is to see if this approach can make hourly walking a habit for at least half of the participants.

How Is the Trial Designed?

Group I: Behavior Change Technique Package Experimental Treatment 1 Intervention

This will be a 12-week, single-arm, multi-component, personalized BCT intervention. Participants will be provided with 4 BCTs daily (Goal Setting, Action Planning, Self-Monitoring, and Prompt/Cue) that have been associated with habit formation theory and development of physical activity habits in prior research.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5129450/

Effectiveness of Caregiver Interventions on Patient ... Evidence is insufficient to endorse use of most caregiver interventions to improve outcomes for patients with dementia or Alzheimer's disease.

2. sciencedirect.com sciencedirect.com/science/article/pii/S104161022402698X

Management of behavioral problems in Alzheimer's disease Regimes involving pleasurable events or caregiver problem-solving techniques were shown to reduce both the rate and severity of depression in AD patients over ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/13607863.2024.2393748

Cognitive behavioural treatment for mild Alzheimer's ... It was shown to be effective in reducing various problem behaviours, such as agitation and depressive behaviour (Teri et al., Citation2003).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12447846/

Transforming Alzheimer's disease nursing: integrating holistic ... Patients receiving integrated care showed significantly improved cognitive stability (ADAS-Cog change: 4.2 ± 3.1 vs. 7.8 ± 3.6 points, p < 0.001) ...

5. jmir.org jmir.org/2017/9/e313/

Components and Outcomes of Internet-Based Interventions ... This study aimed to provide an update on the best available evidence about the efficacy of Internet-based interventions for caregivers of older adults.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3377513/

Caregiver- and Patient-Directed Interventions for Dementia This report features the evidence-based analysis on caregiver- and patient-directed interventions for dementia and is broken down into 4 sections: ...

7. nia.nih.gov nia.nih.gov/health/alzheimers-changes-behavior-and-communication/alzheimers-caregiving-managing-personality-and

Alzheimer's Caregiving: Managing Personality and Behavior ... Tips to manage behavior changes · Be patient, try not to show frustration, and avoid arguing. · Reassure the person that you are there to help.

8. hsrd.research.va.gov hsrd.research.va.gov/publications/esp/DementiaCaregivers-APP.pdf

A Systematic Evidence Review of Interventions for Non- ... Did the study evaluate the effectiveness, safety, or cost of any of the following types of interventions? Psychoeducational interventions .