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

Development of a Prototype FallsTalk Caregiver Resource System

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03961386
Acronym
FT-C
Enrollment
100
Registered
2019-05-23
Start date
2019-03-13
Completion date
2020-05-31
Last updated
2019-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Falls (Accidents) in Old Age

Keywords

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.

Interventions

BEHAVIORALFallsTalk-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.

BEHAVIORALFallsTalk

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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Alzheimer's Association
CollaboratorOTHER
Brookside Research & Development Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Rate of fallsweekly for up to one yearnumber of falls per month
Change of Residenceweekly for up to one yearReport of change of primary residence

Secondary

MeasureTime frameDescription
Fall Threat AwarenessPre-test- 5 clips at Initial interview; Post-test- 5 clips at Follow-up interview one month laterAbility to identify potential fall risks in 10 standardized novel multimedia clips administered in random order
Activity-Specific Balance Confidence scalePre-test at Initial interview; Post-test at Follow-up interview one month laterThe 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.
Caregiver Falls Prevention ConcernsSurvey administered at study entry and Follow-up visit.Specific concerns identified by Caregiver with respect to preventing falls in the person they care for.
Burden Scale for Family CaregiversBSFC is administered at Initial interview and Follow-up interview one month later.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.

Countries

United States

Contacts

Primary ContactBrookside R&D
Info@FallScape.org206-317-3173

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026