Concerns About FallingNCT01358032
Evaluating an In-home Multicomponent Program to Manage Concerns About Falling in Frail Community Dwelling Older People
A study testing an in-home cognitive behavioral program in people with Concerns About Falling and Aged, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The main objectives of this study are: 1. an effect evaluation of an in-home multicomponent cognitive behavioural program on concerns about falling and related avoidance of activity (primary outcomes), as well as disability, fall incidents (secondary outcomes) and several additional outcomes in frail… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Concerns About Falling, Aged
- What is being tested?
- an in-home cognitive behavioral program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2009to May 2011
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 70 years or over
- At least some concerns about falling
- At least some associated avoidance of activity
- Fair or poor perceived general health
- Living independently in the community
- Written informed consent
Who cannot join
- Cognitive impairment (a score of less than 4 on the Abbreviated Mental Test 4)
- Language or hearing problems that impede completing an interview by telephone
- Sight problems that impede completing the intervention
- Confinement to bed
- Waiting for nursing home admission
- Permanent use of a wheelchair
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of an In-home Self-management Intervention to Prevent Psychological Distress in Frail Older People Living in the Community
The main objectives of this study are:
- an effect evaluation of an in-home multicomponent cognitive behavioural program on concerns about falling and related avoidance of activity (primary outcomes), as well as disability, fall incidents (secondary outcomes) and several additional outcomes in frail community-dwelling older people,
- a process evaluation of the feasibility of the program, with the following main outcomes: population reached, performance according to protocol, exposure and engagement, opinion on the program of participants and facilitators, perceived benefit or achievement, and experienced barriers and potential solutions, and
- an economical evaluation on the impact of the program on healthcare utilization and related costs.
- Conditions
- Concerns About Falling, Aged
- Being tested
- an in-home cognitive behavioral program
- Keywords
- Fear of falling, Cognitive behavioral therapy, Randomized controlled trial, Frailty, Accidental Falls
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an in-home cognitive behavioral programBehavioural
The in-home cognitive behavioral program aims to learn older persons, living in the community, how to deal with concerns about falling and to increase physical, social and functional activity. The principles of cognitive restructuring are used for shifting maladaptive in adaptive attitudes with respect to falling as well as increasing self efficacy beliefs and feelings of control. The following themes are discussed during the program: concerns about falling, thoughts about falling, physical exercise, assert oneself, overcome personal barriers, recognizing fall-ty habits and managing concerns about falling. Duration of the program is 10 weeks with 7 individual sessions (3 home visits (60, 60 and 75 minutes, respectively) \& 4 telephone contacts (35 minutes each). The program is facilitated by trained nurses qualified in the field of geriatrics and working for home care agencies.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral program | Experimental | an in-home cognitive behavioral program on managing concerns about falling and associated activity avoidance in frail community-dwelling older people facilitated by trained community nurses. Receives: Behavioral: an in-home cognitive behavioral program |
| Control group | No intervention | no program, only care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
concerns about falling
Falls Efficacy Scale International (FES-I)
Measured: baseline, 5 months and 12 months
avoidance of activities due concerns about falling
Falls Efficacy Scale International Avoidance Behaviour (FES-IAB)
Measured: baseline, 5 months and 12 months
Secondary outcomes (10)
disability
Groningen Activity Restriction Scale (GARS)
Measured: baseline, 5 months and 12 months
number of falls
Fall calendar
Measured: continuous registration during the course of the trial for a period of 1 year
catastrophic beliefs about falling
Catastrophic beliefs about falling (CAFS)
Measured: baseline, 5 months and 12 months
perceived consequences of falling
CoF - loss of functional independence subscale and damage to identity subscale
Measured: baseline, 5 months and 12 months
perceived control over falling
Perceived control over falling (PCOF)
Measured: baseline, 5 months and 12 months
mastery
Personal Mastery Scale
Measured: baseline, 5 months and 12 months
feelings of anxiety
Subscale of the Hospital Anxiety and Depression Scale (HADS-A)
Measured: baseline, 5 months and 12 months
symptoms of depression
Subscale of the Hospital Anxiety and Depression Scale (HADS-D)
Measured: baseline, 5 months and 12 months
social support interactions
Social support interactions (SSL 12-I)
Measured: baseline, 5 months and 12 months
health-related quality of life
SF-12 Health Survey
Measured: baseline, 5 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startMar 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Concerns About FallingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358032
- Sponsor's protocol ID
- MEC 07-3-064
- Other IDs
- ZonMw 120610001
- Status last verified
- Jul 2012
- First submitted
- 17 May 2011
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dorresteijn TA, Rixt Zijlstra GA, Van Eijs YJ, Vlaeyen JW, Kempen GI. Older people's preferences regarding programme formats for managing concerns about falls. Age Ageing. 2012 Jul;41(4):474-81. doi: 10.1093/ageing/afs007. Epub 2012 Feb 23.
PubMed 22367355Dorresteijn TA, Zijlstra GA, Delbaere K, van Rossum E, Vlaeyen JW, Kempen GI. Evaluating an in-home multicomponent cognitive behavioural programme to manage concerns about falls and associated activity avoidance in frail community-dwelling older people: Design of a randomised control trial [NCT01358032]. BMC Health Serv Res. 2011 Sep 20;11:228. doi: 10.1186/1472-6963-11-228.
PubMed 21933436Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.
PubMed 39360568Kruisbrink M, Zijlstra GAR, Crutzen R, Dorresteijn TAC, Winkens B, Kempen GIJM. Participant Characteristics as Moderators of the Effects of Cognitive Behavioral Interventions on Concerns About Falling: Secondary Analyses of Two Randomized Controlled Trials. J Appl Gerontol. 2023 Aug;42(8):1877-1887. doi: 10.1177/07334648231165904. Epub 2023 Apr 6.
PubMed 37026185Evers SMAA, Dorresteijn TAC, Wijnen BFM, van Haastregt JCM, Kempen GIJM, Zijlstra GAR. Economic evaluation of a home-based programme to reduce concerns about falls in frail, independently-living older people. Expert Rev Pharmacoecon Outcomes Res. 2020 Dec;20(6):641-651. doi: 10.1080/14737167.2019.1666714. Epub 2019 Sep 20.
PubMed 31502897Dorresteijn TA, Zijlstra GA, Ambergen AW, Delbaere K, Vlaeyen JW, Kempen GI. Effectiveness of a home-based cognitive behavioral program to manage concerns about falls in community-dwelling, frail older people: results of a randomized controlled trial. BMC Geriatr. 2016 Jan 6;16:2. doi: 10.1186/s12877-015-0177-y.
PubMed 26739339Dorresteijn TA, Rixt Zijlstra GA, Van Haastregt JC, Vlaeyen JW, Kempen GI. Feasibility of a nurse-led in-home cognitive behavioral program to manage concerns about falls in frail older people: a process evaluation. Res Nurs Health. 2013 Jun;36(3):257-70. doi: 10.1002/nur.21534. Epub 2013 Mar 26.
PubMed 23533013
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of an In-home Self-management Intervention to Prevent Psychological Distress in Frail Older People Living in the Community
- ClinicalTrials.gov ID
- NCT01358032
- Acronym / sponsor ID
- MEC 07-3-064
- Conditions
- Concerns About Falling, Aged
- Keywords
- Fear of falling, Cognitive behavioral therapy, Randomized controlled trial, Frailty, Accidental Falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Mar 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 23 May 2011 (estimated)
- 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.
The main objectives of this study are:
- an effect evaluation of an in-home multicomponent cognitive behavioural program on concerns about falling and related avoidance of activity (primary outcomes), as well as disability, fall incidents (secondary outcomes) and several additional outcomes in frail community-dwelling older people,
- a process evaluation of the feasibility of the program, with the following main outcomes: population reached, performance according to protocol, exposure and engagement, opinion on the program of participants and facilitators, perceived benefit or achievement, and experienced barriers and potential solutions, and
- an economical evaluation on the impact of the program on healthcare utilization and related costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral program | Experimental | Behavioral: an in-home cognitive behavioral programan in-home cognitive behavioral program on managing concerns about falling and associated activity avoidance in frail community-dwelling older people facilitated by trained community nurses. |
| Control group | No intervention | –no program, only care as usual |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Aged 70 years or over
- At least some concerns about falling
- At least some associated avoidance of activity
- Fair or poor perceived general health
- Living independently in the community
Key exclusion criteria (6 listed)
- Cognitive impairment (a score of less than 4 on the Abbreviated Mental Test 4)
- Language or hearing problems that impede completing an interview by telephone
- Sight problems that impede completing the intervention
- Confinement to bed
- Waiting for nursing home admission
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 |
|---|---|---|
| an in-home cognitive behavioral programThe in-home cognitive behavioral program aims to learn older persons, living in the community, how to deal with concerns about falling and to increase physical, social and functional activity. The principles of cognitive restructuring are used for shifting maladaptive in adaptive attitudes with respect to falling as well as increasing self efficacy beliefs and feelings of control. The following themes are discussed during the program: concerns about falling, thoughts about falling, physical exercise, assert oneself, overcome personal barriers, recognizing fall-ty habits and managing concerns about falling. Duration of the program is 10 weeks with 7 individual sessions (3 home visits (60, 60 and 75 minutes, respectively) \& 4 telephone contacts (35 minutes each). The program is facilitated by trained nurses qualified in the field of geriatrics and working for home care agencies. | Behavioural | Cognitive behavioral program |
Primary outcome
concerns about falling
Time frame: baseline, 5 months and 12 months
Falls Efficacy Scale International (FES-I)
avoidance of activities due concerns about falling
Time frame: baseline, 5 months and 12 months
Falls Efficacy Scale International Avoidance Behaviour (FES-IAB)
10 secondary outcomes
disability
Time frame: baseline, 5 months and 12 months
number of falls
Time frame: continuous registration during the course of the trial for a period of 1 year
catastrophic beliefs about falling
Time frame: baseline, 5 months and 12 months
perceived consequences of falling
Time frame: baseline, 5 months and 12 months
perceived control over falling
Time frame: baseline, 5 months and 12 months
mastery
Time frame: baseline, 5 months and 12 months
feelings of anxiety
Time frame: baseline, 5 months and 12 months
symptoms of depression
Time frame: baseline, 5 months and 12 months
social support interactions
Time frame: baseline, 5 months and 12 months
health-related quality of life
Time frame: baseline, 5 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
- Background: PubMed 22367355Dorresteijn TA, Rixt Zijlstra GA, Van Eijs YJ, Vlaeyen JW, Kempen GI. Older people's preferences regarding programme formats for managing concerns about falls. Age Ageing. 2012 Jul;41(4):474-81. doi: 10.1093/ageing/afs007. Epub 2012 Feb 23.
- Background: PubMed 21933436Dorresteijn TA, Zijlstra GA, Delbaere K, van Rossum E, Vlaeyen JW, Kempen GI. Evaluating an in-home multicomponent cognitive behavioural programme to manage concerns about falls and associated activity avoidance in frail community-dwelling older people: Design of a randomised control trial [NCT01358032]. BMC Health Serv Res. 2011 Sep 20;11:228. doi: 10.1186/1472-6963-11-228.
- Derived from this study: PubMed 39360568Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.
- Derived from this study: PubMed 37026185Kruisbrink M, Zijlstra GAR, Crutzen R, Dorresteijn TAC, Winkens B, Kempen GIJM. Participant Characteristics as Moderators of the Effects of Cognitive Behavioral Interventions on Concerns About Falling: Secondary Analyses of Two Randomized Controlled Trials. J Appl Gerontol. 2023 Aug;42(8):1877-1887. doi: 10.1177/07334648231165904. Epub 2023 Apr 6.
- Derived from this study: PubMed 31502897Evers SMAA, Dorresteijn TAC, Wijnen BFM, van Haastregt JCM, Kempen GIJM, Zijlstra GAR. Economic evaluation of a home-based programme to reduce concerns about falls in frail, independently-living older people. Expert Rev Pharmacoecon Outcomes Res. 2020 Dec;20(6):641-651. doi: 10.1080/14737167.2019.1666714. Epub 2019 Sep 20.
- Derived from this study: PubMed 26739339Dorresteijn TA, Zijlstra GA, Ambergen AW, Delbaere K, Vlaeyen JW, Kempen GI. Effectiveness of a home-based cognitive behavioral program to manage concerns about falls in community-dwelling, frail older people: results of a randomized controlled trial. BMC Geriatr. 2016 Jan 6;16:2. doi: 10.1186/s12877-015-0177-y.
- Derived from this study: PubMed 23533013Dorresteijn TA, Rixt Zijlstra GA, Van Haastregt JC, Vlaeyen JW, Kempen GI. Feasibility of a nurse-led in-home cognitive behavioral program to manage concerns about falls in frail older people: a process evaluation. Res Nurs Health. 2013 Jun;36(3):257-70. doi: 10.1002/nur.21534. Epub 2013 Mar 26.
Related trials for Concerns About Falling
Not yet recruiting
Educational Interventions to Reduce Concerns About Falling, Falls and Associated Outcomes Among Older Adults
Concerns About Falling, Falls
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing an in-home cognitive behavioral program in people with Concerns About Falling and Aged, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. 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: finished, as of the sponsor's last update on 10 Jul 2012. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concerns about falling (time frame: baseline, 5 months and 12 months). 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?
On the ClinicalTrials.gov record for NCT01358032, which also lists 7 linked publications.
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 10 Jul 2012.