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

Not Applicable

Completed

• Conditions: Concerns About Falling; Aged
• Interventions: Behavioral: an in-home cognitive behavioral program

• Registration Number: NCT01358032
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-05-17
• Study First Submitted QC: 2011-05-19
• Study First Posted: 2011-05-23
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 389

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive behavioral program	an in-home cognitive behavioral program	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.

Primary Outcome Measures

Name	Time	Method
concerns about falling	baseline, 5 months and 12 months	Falls Efficacy Scale International (FES-I)
avoidance of activities due concerns about falling	baseline, 5 months and 12 months	Falls Efficacy Scale International Avoidance Behaviour (FES-IAB)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Netherlands