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

Study Overview
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Brief Summary
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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.

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

Conditions
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Concerns About Falling, Aged

Intervention / Treatment
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* Behavioral: an in-home cognitive behavioral program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behavioral program<br>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. | Behavioral: an in-home cognitive behavioral program<br>* 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.<br>|
| No Intervention: Control group<br>no program, only care as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concerns about falling | Falls Efficacy Scale International (FES-I) | baseline, 5 months and 12 months | 
| avoidance of activities due concerns about falling | Falls Efficacy Scale International Avoidance Behaviour (FES-IAB) | baseline, 5 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disability | Groningen Activity Restriction Scale (GARS) | baseline, 5 months and 12 months | 
| number of falls | Fall calendar | continuous registration during the course of the trial for a period of 1 year | 
| catastrophic beliefs about falling | Catastrophic beliefs about falling (CAFS) | baseline, 5 months and 12 months | 
| perceived consequences of falling | CoF - loss of functional independence subscale and damage to identity subscale | baseline, 5 months and 12 months | 
| perceived control over falling | Perceived control over falling (PCOF) | baseline, 5 months and 12 months | 
| mastery | Personal Mastery Scale | baseline, 5 months and 12 months | 
| feelings of anxiety | Subscale of the Hospital Anxiety and Depression Scale (HADS-A) | baseline, 5 months and 12 months | 
| symptoms of depression | Subscale of the Hospital Anxiety and Depression Scale (HADS-D) | baseline, 5 months and 12 months | 
| social support interactions | Social support interactions (SSL 12-I) | baseline, 5 months and 12 months | 
| health-related quality of life | SF-12 Health Survey | baseline, 5 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fear of falling, Cognitive behavioral therapy, Randomized controlled trial, Frailty, Accidental Falls