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Completed

NCT Number: NCT01358032

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

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.

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Key information

Conditions

Concerns About Falling Aged Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, 6221 GT, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

an in-home cognitive behavioral program

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 23, 2011
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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