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

July 9, 2012 updated by: Maastricht University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

389

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6221 GT
        • Maastricht University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: an 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.
No Intervention: Control group
no program, only care as usual

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

May 17, 2011

First Submitted That Met QC Criteria

May 19, 2011

First Posted (Estimate)

May 23, 2011

Study Record Updates

Last Update Posted (Estimate)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 9, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MEC 07-3-064
  • ZonMw 120610001 (Other Grant/Funding Number: ZonMw 120610001)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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