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
  Purpose

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 Intervention
Concerns About Falling
Aged
Behavioral: an in-home cognitive behavioral program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Enrollment: 389
Study Start Date: March 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358032

Locations
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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01358032     History of Changes
Other Study ID Numbers: MEC 07-3-064, ZonMw 120610001
Study First Received: May 17, 2011
Last Updated: July 9, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Fear of falling
Cognitive behavioral therapy
Randomized controlled trial
Frailty
Accidental Falls

ClinicalTrials.gov processed this record on August 01, 2014