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

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01358032
First received: May 17, 2011
Last updated: July 9, 2012
Last verified: July 2012

May 17, 2011
July 9, 2012
March 2009
May 2011   (final data collection date for primary outcome measure)
  • concerns about falling [ Time Frame: baseline, 5 months and 12 months ] [ Designated as safety issue: No ]
    Falls Efficacy Scale International (FES-I)
  • avoidance of activities due concerns about falling [ Time Frame: baseline, 5 months and 12 months ] [ Designated as safety issue: No ]
    Falls Efficacy Scale International Avoidance Behaviour (FES-IAB)
Same as current
Complete list of historical versions of study NCT01358032 on ClinicalTrials.gov Archive Site
  • disability [ Time Frame: baseline, 5 months and 12 months ] [ Designated as safety issue: No ]
    Groningen Activity Restriction Scale (GARS)
  • number of falls [ Time Frame: continuous registration during the course of the trial for a period of 1 year ] [ Designated as safety issue: No ]
    Fall calendar
  • catastrophic beliefs about falling [ Time Frame: baseline, 5 months and 12 months ] [ Designated as safety issue: No ]
    Catastrophic beliefs about falling (CAFS)
  • perceived consequences of falling [ Time Frame: baseline, 5 months and 12 months ] [ Designated as safety issue: No ]
    CoF - loss of functional independence subscale and damage to identity subscale
  • perceived control over falling [ Time Frame: baseline, 5 months and 12 months ] [ Designated as safety issue: No ]
    Perceived control over falling (PCOF)
  • mastery [ Time Frame: baseline, 5 months and 12 months ] [ Designated as safety issue: No ]
    Personal Mastery Scale
  • feelings of anxiety [ Time Frame: baseline, 5 months and 12 months ] [ Designated as safety issue: No ]
    Subscale of the Hospital Anxiety and Depression Scale (HADS-A)
  • symptoms of depression [ Time Frame: baseline, 5 months and 12 months ] [ Designated as safety issue: No ]
    Subscale of the Hospital Anxiety and Depression Scale (HADS-D)
  • social support interactions [ Time Frame: baseline, 5 months and 12 months ] [ Designated as safety issue: No ]
    Social support interactions (SSL 12-I)
  • health-related quality of life [ Time Frame: baseline, 5 months and 12 months ] [ Designated as safety issue: No ]
    SF-12 Health Survey
Same as current
Not Provided
Not Provided
 
Evaluating an In-home Multicomponent Program to Manage Concerns About Falling in Frail Community Dwelling Older People
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Concerns About Falling
  • Aged
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.
  • 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.
    Intervention: Behavioral: an in-home cognitive behavioral program
  • No Intervention: Control group
    no program, only care as usual

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
389
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01358032
MEC 07-3-064, ZonMw 120610001
Yes
Maastricht University Medical Center
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Not Provided
Maastricht University Medical Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP