Falls (Accidents) in Old AgeFT-CNCT03961386
FallsTalk Falls Prevention Program for Caregivers and Persons With Memory Loss or Dementia
A study testing FallsTalk-C and FallsTalk in people with Falls (Accidents) in Old Age, run by Brookside Research & Development Company at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Falls (Accidents) in Old Age
- What is being tested?
- FallsTalk-C and FallsTalk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2019to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brookside Research & Development
Freeland, Washington, 98249
Victoria Panzer, PhD, 206-317-3173, VPBrookside@fallscape.org
Kristin Koontz, RN, 206-317-3173, Info@fallscape.org
About this study
Official title: Development of a Prototype FallsTalk Caregiver Resource System
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.
Read the detailed description
This is a single-site preliminary trial enrolling dyads in Western Washington state only.
- Conditions
- Falls (Accidents) in Old Age
- Being tested
- FallsTalk-C, FallsTalk
- Keywords
- prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FallsTalk-CBehavioural
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.
FallsTalkBehavioural
Also called Attentional control- the same number of steps and an equivalent amount of time is devoted to these participants.
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.
| Study group | Role | What they receive |
|---|---|---|
| FallsTalk-C | Experimental | FallsTalk CG intervention Receives: Behavioral: FallsTalk-C; Behavioral: FallsTalk |
| FallsTalk | Active comparator | FallsTalk intervention Receives: Behavioral: FallsTalk |
| PostCardOnly | No intervention | Postcard only- Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of falls
number of falls per month
Measured: weekly for up to one year
Change of Residence
Report of change of primary residence
Measured: weekly for up to one year
Secondary outcomes (4)
Fall Threat Awareness
Ability to identify potential fall risks in 10 standardized novel multimedia clips administered in random order
Measured: 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.
Measured: 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.
Measured: 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.
Measured: BSFC is administered at Initial interview and Follow-up interview one month later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start13 Mar 2019
- Primary completionDec 2019 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Falls (Accidents) in Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brookside Research & Development Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Alzheimer's Association
- Responsible party
- Sponsor
- Investigators
- Victoria Panzer, PhD, Principal investigator, Brookside Research & Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961386
- Sponsor's protocol ID
- FT-Cv1.1
- Other IDs
- R43AG058399
- Acronym
- FT-C
- Status last verified
- Jun 2019
- First submitted
- 22 May 2019
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Prototype FallsTalk Caregiver Resource System
- ClinicalTrials.gov ID
- NCT03961386
- Acronym / sponsor ID
- FT-C / FT-Cv1.1
- Conditions
- Falls (Accidents) in Old Age
- Keywords
- prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brookside Research & Development CompanyIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Alzheimer's Association
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FallsTalk-C | Experimental | Behavioral: FallsTalk-C, Behavioral: FallsTalkFallsTalk CG intervention |
| FallsTalk | Active comparator | Behavioral: FallsTalkFallsTalk intervention |
| PostCardOnly | No intervention | –Postcard only- Control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FallsTalk-CThe 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. | Behavioural | FallsTalk-C |
| FallsTalkAlso: Attentional control- the same number of steps and an equivalent amount of time is devoted to these participants.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. | Behavioural | FallsTalk, FallsTalk-C |
Primary outcome
Rate of falls
Time frame: weekly for up to one year
number of falls per month
Change of Residence
Time frame: weekly for up to one year
Report of change of primary residence
4 secondary outcomes
Fall Threat Awareness
Time frame: Pre-test- 5 clips at Initial interview; Post-test- 5 clips at Follow-up interview one month later
Activity-Specific Balance Confidence scale
Time frame: Pre-test at Initial interview; Post-test at Follow-up interview one month later
Caregiver Falls Prevention Concerns
Time frame: Survey administered at study entry and Follow-up visit.
Burden Scale for Family Caregivers
Time frame: BSFC is administered at Initial interview and Follow-up interview one month later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Panzer, PhD principal investigator
Brookside Research & Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FallsTalk-C and FallsTalk in people with Falls (Accidents) in Old Age, run by Brookside Research & Development Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brookside R&D (206-317-3173, Info@FallScape.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of falls (time frame: weekly for up to one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.