FallsTalk Falls Prevention Program for Caregivers and Persons With Memory Loss or Dementia

NCT ID: NCT03961386

Last Updated: 2019-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-13

Study Completion Date

2020-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This randomized-control trial involves dyads consisting of a family caregiver (CG) and a person with memory loss or dementia (PwD). The FallsTalk Caregiver Resource System (FT-C) intervention is administered by the CG, whose role is to modify their interactions with the PwD. FT-C will create a 3-way partnership between an Interventionist and the dyad, capitalizing on CG-PwD interactions. The PwD will be observed by the CG and both will be evaluated by the study team. Brief daily FT-C intervention by the CG will stimulate the PwD's awareness and individualized weekly CG- check-ins with the Interventionist will increase the CG's skills. Our hypothesis is that FT-C will increase PwD's awareness of personal fall threats and encourage new falls prevention behaviors, resulting in reduced fall rates.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a single-site preliminary trial enrolling dyads in Western Washington state only.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Falls (Accidents) in Old Age

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FallsTalk-C

FallsTalk CG intervention

Group Type EXPERIMENTAL

FallsTalk-C

Intervention Type BEHAVIORAL

The FT-C experimental intervention involves two face-to-face visits including Initial and Follow-up Interviews, CG training, daily interaction with the PwD using a computer with FT-C software, weekly check-in calls, weekly postcard completion and monthly check-in calls for at least six months and up to one year.

FallsTalk

Intervention Type BEHAVIORAL

The FallsTalk intervention involves two face-to-face visits including Initial and Follow-up Interviews,CG training, daily interaction with the PwD, weekly check-in calls, weekly postcard completion and monthly check-in calls for at least six months and up to one year.

FallsTalk

FallsTalk intervention

Group Type ACTIVE_COMPARATOR

FallsTalk

Intervention Type BEHAVIORAL

The FallsTalk intervention involves two face-to-face visits including Initial and Follow-up Interviews,CG training, daily interaction with the PwD, weekly check-in calls, weekly postcard completion and monthly check-in calls for at least six months and up to one year.

PostCardOnly

Postcard only- Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FallsTalk-C

The FT-C experimental intervention involves two face-to-face visits including Initial and Follow-up Interviews, CG training, daily interaction with the PwD using a computer with FT-C software, weekly check-in calls, weekly postcard completion and monthly check-in calls for at least six months and up to one year.

Intervention Type BEHAVIORAL

FallsTalk

The FallsTalk intervention involves two face-to-face visits including Initial and Follow-up Interviews,CG training, daily interaction with the PwD, weekly check-in calls, weekly postcard completion and monthly check-in calls for at least six months and up to one year.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Attentional control- the same number of steps and an equivalent amount of time is devoted to these participants.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* residence in western Washington state
* minimum age= 18
* family CG
* primary CG
* some daily personal contact with Person with Dementia (PwD) for 1 month
* basic computer skills and telephone access
* able to commit to 6 month study.


* living at home with residence in western Washington state
* minimum age= 55
* at least one fall in last 6 months or regular loss of balance
* can ambulate at least 6 feet
* ability to communicate thoughts
* willingness to participate.

Exclusion Criteria

* Professional CG (unless primary CG for family member)
* distance CG unable to be physically present with PwD daily for 1 month
* terminal illness with less than 6 months to live
* CG has significant memory loss.


* Residence outside of western Washington state
* Living in Residential care setting
* non-communicative
* terminal illness with less than 6 months to live
* wheel chair or bed bound.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Alzheimer's Association

OTHER

Sponsor Role collaborator

Brookside Research & Development Company

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Victoria Panzer, PhD

Role: PRINCIPAL_INVESTIGATOR

Brookside Research & Development

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brookside Research & Development

Freeland, Washington, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Brookside R&D

Role: CONTACT

206-317-3173

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Victoria Panzer, PhD

Role: primary

206-317-3173

Kristin Koontz, RN

Role: backup

206-317-3173

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R43AG058399

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FT-Cv1.1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Nightlight Falls Prevention Study
NCT05973448 ENROLLING_BY_INVITATION NA