Clinical trial NCT03961386: FallsTalk Falls Prevention Program for Caregivers and Persons With Memory Loss or Dementia
Official title: Development of a Prototype FallsTalk Caregiver Resource System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Falls (Accidents) in Old Age
Keywords: prevention
Lead sponsor: Brookside Research & Development Company
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
name: Alzheimer's Association
First posted: 2019-05-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of falls
timeFrame: weekly for up to one year
measure: Change of Residence
timeFrame: weekly for up to one year
Secondary outcomes:
measure: Fall Threat Awareness
timeFrame: Pre-test- 5 clips at Initial interview; Post-test- 5 clips at Follow-up interview one month later
measure: Activity-Specific Balance Confidence scale
timeFrame: Pre-test at Initial interview; Post-test at Follow-up interview one month later
measure: Caregiver Falls Prevention Concerns
timeFrame: Survey administered at study entry and Follow-up visit.
measure: Burden Scale for Family Caregivers
timeFrame: BSFC is administered at Initial interview and Follow-up interview one month later.
Other outcomes:
Locations:
city: Freeland
country: United States
facility: Brookside Research & Development
state: Washington
Study officials:
affiliation: Brookside Research & Development
name: Victoria Panzer, PhD
role: PRINCIPAL_INVESTIGATOR
References: