We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01358032
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : July 10, 2012
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Concerns About Falling Aged Behavioral: an in-home cognitive behavioral program Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 389 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Effectiveness of an In-home Self-management Intervention to Prevent Psychological Distress in Frail Older People Living in the Community
Study Start Date : March 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. concerns about falling [ Time Frame: baseline, 5 months and 12 months ]
    Falls Efficacy Scale International (FES-I)

  2. avoidance of activities due concerns about falling [ Time Frame: baseline, 5 months and 12 months ]
    Falls Efficacy Scale International Avoidance Behaviour (FES-IAB)


Secondary Outcome Measures :
  1. disability [ Time Frame: baseline, 5 months and 12 months ]
    Groningen Activity Restriction Scale (GARS)

  2. number of falls [ Time Frame: continuous registration during the course of the trial for a period of 1 year ]
    Fall calendar

  3. catastrophic beliefs about falling [ Time Frame: baseline, 5 months and 12 months ]
    Catastrophic beliefs about falling (CAFS)

  4. perceived consequences of falling [ Time Frame: baseline, 5 months and 12 months ]
    CoF - loss of functional independence subscale and damage to identity subscale

  5. perceived control over falling [ Time Frame: baseline, 5 months and 12 months ]
    Perceived control over falling (PCOF)

  6. mastery [ Time Frame: baseline, 5 months and 12 months ]
    Personal Mastery Scale

  7. feelings of anxiety [ Time Frame: baseline, 5 months and 12 months ]
    Subscale of the Hospital Anxiety and Depression Scale (HADS-A)

  8. symptoms of depression [ Time Frame: baseline, 5 months and 12 months ]
    Subscale of the Hospital Anxiety and Depression Scale (HADS-D)

  9. social support interactions [ Time Frame: baseline, 5 months and 12 months ]
    Social support interactions (SSL 12-I)

  10. health-related quality of life [ Time Frame: baseline, 5 months and 12 months ]
    SF-12 Health Survey


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358032


Locations
Layout table for location information
Netherlands
Maastricht University
Maastricht, Netherlands, 6221 GT
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01358032    
Other Study ID Numbers: MEC 07-3-064
ZonMw 120610001 ( Other Grant/Funding Number: ZonMw 120610001 )
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012
Keywords provided by Maastricht University Medical Center:
Fear of falling
Cognitive behavioral therapy
Randomized controlled trial
Frailty
Accidental Falls