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

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ClinicalTrials.gov Identifier: NCT03961386
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Alzheimer's Association- Washington State Chapter
Information provided by (Responsible Party):
Brookside Research & Development Company

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.

Condition or disease Intervention/treatment Phase
Falls (Accidents) in Old Age Behavioral: FallsTalk-C Behavioral: FallsTalk Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Development of a Prototype FallsTalk Caregiver Resource System
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Falls

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 Name: 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 Name: 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



Primary Outcome Measures :
  1. Rate of falls [ Time Frame: weekly for up to one year ]
    number of falls per month

  2. Change of Residence [ Time Frame: weekly for up to one year ]
    Report of change of primary residence


Secondary Outcome Measures :
  1. Fall Threat Awareness [ Time Frame: Pre-test- 5 clips at Initial interview; Post-test- 5 clips at Follow-up interview one month later ]
    Ability to identify potential fall risks in 10 standardized novel multimedia clips administered in random order

  2. Activity-Specific Balance Confidence scale [ Time Frame: Pre-test at Initial interview; Post-test at Follow-up interview one month later ]
    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.

  3. Caregiver Falls Prevention Concerns [ Time Frame: Survey administered at study entry and Follow-up visit. ]
    Specific concerns identified by Caregiver with respect to preventing falls in the person they care for.

  4. Burden Scale for Family Caregivers [ Time Frame: BSFC 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961386


Contacts
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Contact: Brookside R&D 206-317-3173 Info@FallScape.org

Locations
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United States, Washington
Brookside Research & Development Recruiting
Freeland, Washington, United States, 98249
Contact: Victoria Panzer, PhD    206-317-3173    VPBrookside@fallscape.org   
Contact: Kristin Koontz, RN    206-317-3173    Info@fallscape.org   
Principal Investigator: Victoria Panzer, PhD         
Sponsors and Collaborators
Brookside Research & Development Company
National Institute on Aging (NIA)
Alzheimer's Association- Washington State Chapter
Investigators
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Principal Investigator: Victoria Panzer, PhD Brookside Research & Development

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Responsible Party: Brookside Research & Development Company
ClinicalTrials.gov Identifier: NCT03961386     History of Changes
Other Study ID Numbers: FT-Cv1.1
R43AG058399 ( U.S. NIH Grant/Contract )
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brookside Research & Development Company:
prevention