Clinical trial NCT01358032: Evaluating an In-home Multicomponent Program to Manage Concerns About Falling in Frail Community Dwelling Older People
Official title: Evaluating the Effectiveness of an In-home Self-management Intervention to Prevent Psychological Distress in Frail Older People Living in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concerns About Falling
Aged
Keywords: Fear of falling
Cognitive behavioral therapy
Randomized controlled trial
Frailty
Accidental Falls
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2011-05-23
Enrollment: 389
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 community-dwelling older people,
2. 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
3. an economical evaluation on the impact of the program on healthcare utilization and related costs.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: concerns about falling
timeFrame: baseline, 5 months and 12 months
measure: avoidance of activities due concerns about falling
timeFrame: baseline, 5 months and 12 months
Secondary outcomes:
measure: disability
timeFrame: baseline, 5 months and 12 months
measure: number of falls
timeFrame: continuous registration during the course of the trial for a period of 1 year
measure: catastrophic beliefs about falling
timeFrame: baseline, 5 months and 12 months
measure: perceived consequences of falling
timeFrame: baseline, 5 months and 12 months
measure: perceived control over falling
timeFrame: baseline, 5 months and 12 months
measure: mastery
timeFrame: baseline, 5 months and 12 months
measure: feelings of anxiety
timeFrame: baseline, 5 months and 12 months
measure: symptoms of depression
timeFrame: baseline, 5 months and 12 months
measure: social support interactions
timeFrame: baseline, 5 months and 12 months
measure: health-related quality of life
timeFrame: baseline, 5 months and 12 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
References:
citation: 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.
citation: Dorresteijn 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.
citation: Evers 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.
citation: Dorresteijn 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.
citation: Dorresteijn 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.