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

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

Official Title
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Development of a Prototype FallsTalk Caregiver Resource System

Conditions
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Falls (Accidents) in Old Age

Intervention / Treatment
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* Behavioral: FallsTalk-C
* Behavioral: FallsTalk


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention