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Evaluating an In-home Multicomponent Program to Manage Concerns About Falling in Frail Community Dwelling Older People

Evaluating the Effectiveness of an In-home Self-management Intervention to Prevent Psychological Distress in Frail Older People Living in the Community

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01358032
Enrollment
389
Registered
2011-05-23
Start date
2009-03-31
Completion date
2011-05-31
Last updated
2012-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aged, Concerns About Falling

Keywords

Fear of falling, Cognitive behavioral therapy, Randomized controlled trial, Frailty, Accidental Falls

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.

Interventions

BEHAVIORALan in-home cognitive behavioral program

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.

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development
CollaboratorOTHER
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
concerns about fallingbaseline, 5 months and 12 monthsFalls Efficacy Scale International (FES-I)
avoidance of activities due concerns about fallingbaseline, 5 months and 12 monthsFalls Efficacy Scale International Avoidance Behaviour (FES-IAB)

Secondary

MeasureTime frameDescription
catastrophic beliefs about fallingbaseline, 5 months and 12 monthsCatastrophic beliefs about falling (CAFS)
perceived consequences of fallingbaseline, 5 months and 12 monthsCoF - loss of functional independence subscale and damage to identity subscale
perceived control over fallingbaseline, 5 months and 12 monthsPerceived control over falling (PCOF)
masterybaseline, 5 months and 12 monthsPersonal Mastery Scale
disabilitybaseline, 5 months and 12 monthsGroningen Activity Restriction Scale (GARS)
symptoms of depressionbaseline, 5 months and 12 monthsSubscale of the Hospital Anxiety and Depression Scale (HADS-D)
social support interactionsbaseline, 5 months and 12 monthsSocial support interactions (SSL 12-I)
health-related quality of lifebaseline, 5 months and 12 monthsSF-12 Health Survey
feelings of anxietybaseline, 5 months and 12 monthsSubscale of the Hospital Anxiety and Depression Scale (HADS-A)
number of fallscontinuous registration during the course of the trial for a period of 1 yearFall calendar

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026