FallsTalk Falls Prevention Program for Caregivers and Persons With Memory Loss or Dementia (FT-C)

Development of a Prototype FallsTalk Caregiver Resource System

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.

Study Overview

• Status: Unknown
• Conditions: Falls (Accidents) in Old Age
• Intervention / Treatment: Behavioral: FallsTalk-C; Behavioral: FallsTalk

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Freeland, Washington, United States, 98249
      • Recruiting
      • Brookside Research & Development
      • Contact: Victoria Panzer, PhD; Phone Number: 206-317-3173; Email: VPBrookside@fallscape.org
      • Contact: Kristin Koontz, RN; Phone Number: 206-317-3173; Email: Info@fallscape.org
      • Principal Investigator: Victoria Panzer, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FallsTalk-C; FallsTalk CG intervention	Behavioral: 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.; 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.; Other Names: Attentional control- the same number of steps and an equivalent amount of time is devoted to these participants.
Active Comparator: FallsTalk; FallsTalk intervention	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.; Other Names: Attentional control- the same number of steps and an equivalent amount of time is devoted to these participants.
No Intervention: PostCardOnly; Postcard only- Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of falls	number of falls per month	weekly for up to one year
Change of Residence	Report of change of primary residence	weekly for up to one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall Threat Awareness	Ability to identify potential fall risks in 10 standardized novel multimedia clips administered in random order	Pre-test- 5 clips at Initial interview; Post-test- 5 clips at Follow-up interview one month later
Activity-Specific Balance Confidence scale	The Activity-Specific Balance Confidence scale is a standardized 16 item scale that measures an individual's self-efficacy about preventing a fall or loss of balance. The maximum score is 1600. Each item is scored from 0-100 with 0 indicating no confidence and 100 meaning complete confidence.	Pre-test at Initial interview; Post-test at Follow-up interview one month later
Caregiver Falls Prevention Concerns	Specific concerns identified by Caregiver with respect to preventing falls in the person they care for.	Survey administered at study entry and Follow-up visit.
Burden Scale for Family Caregivers	The Burden Scale for Family Caregivers is a standardized 28 item scale that assesses subjective burden of the CG. The items are scored as strongly agree, agree, disagree or strongly disagree and the maximum score is 84. A score of 0 indicates no burden and a score of 84 indicates a very severe burden with a high risk of psychosomatic symptoms.	BSFC is administered at Initial interview and Follow-up interview one month later.

Collaborators and Investigators

• Sponsor: Brookside Research & Development Company
• Collaborators: National Institute on Aging (NIA); Alzheimer's Association
• Investigators: Principal Investigator: Victoria Panzer, PhD, Brookside Research & Development

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: prevention
• Other Study ID Numbers: FT-Cv1.1; R43AG058399 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No