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

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Concerns About Falling; Aged

Treatments: Behavioral: an in-home cognitive behavioral program

Study type: Interventional

Funder types: Other

Identifiers

NCT01358032

MEC 07-3-064

ZonMw 120610001 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 389 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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389 participants in 2 patient groups

Cognitive behavioral program

Experimental group

Description:

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.

Treatment:

Behavioral: an in-home cognitive behavioral program

Control group

No Intervention group

Description:

no program, only care as usual