Recruiting

FallsTalk

Sponsor:

Brookside Research & Development Company

Code:

NCT03961386

Conditions

Falls (Accidents) in Old Age

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FallsTalk-C

FallsTalk

Study Details

Brief summary:

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.

Conditions

Falls (Accidents) in Old Age

Study ID

NCT03961386

Start date

Mar 13, 2019

Status verified date

Jun, 2019

Completion date

May, 2020

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Caregiver (CG) 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.

Persons with Dementia (PwD) Inclusion Criteria:

  • 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.

CG 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.

PwD Exclusion Criteria:

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: FallsTalk-C

FallsTalk CG intervention

active comparator: FallsTalk

FallsTalk intervention

no intervention: PostCardOnly

Postcard only- Control group

Interventions

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.

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.

Primary outcome measure

  • Rate of falls [ Time Frame: weekly for up to one year ]
  • Change of Residence [ Time Frame: weekly for up to one year ]

Central Contacts and Locations

Central contacts

Brookside R&D

206-317-3173Info@FallScape.org

Locations

Brookside Research & Development

Recruiting

Freeland, Washington, United States, 98249

Contacts

Victoria Panzer, PhD

206-317-3173VPBrookside@fallscape.org

Kristin Koontz, RN

206-317-3173Info@fallscape.org

Principal Investigator:

Victoria Panzer, PhD

More Information

Sponsor

Brookside Research & Development Company

Last update posted

Jun 6, 2019

Last verified

Jun, 2019

Keywords

  • prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brookside Research & Development Company on 2019-06-06.