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

Falls (Accidents) in Old Age Clinical Trial

— FT-C  

Official title:

Development of a Prototype FallsTalk Caregiver Resource System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03961386
• Other study ID #: FT-Cv1.1
• Secondary ID: R43AG058399
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2019
• Est. completion date: May 2020

Study information

• Verified date: June 2019
• Source: Brookside Research & Development Company
• Contact: Brookside R&D
• Phone: 206-317-3173
• Email: Info[@]FallScape.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Falls (Accidents) in Old Age

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.
• 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.

Locations

Country	Name	City	State
United States	Brookside Research & Development	Freeland	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Brookside Research & Development Company	Alzheimer's Association- Washington State Chapter, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of falls	number of falls per month	weekly for up to one year
Primary	Change of Residence	Report of change of primary residence	weekly for up to one year
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.