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

History of Changes

Tracking Information
First Received Date ^ICMJE	May 17, 2011
Last Updated Date	July 9, 2012
Start Date ^ICMJE	March 2009
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 19, 2011)	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)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01358032 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 19, 2011)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluating an In-home Multicomponent Program to Manage Concerns About Falling in Frail Community Dwelling Older People
Official Title ^ICMJE	Evaluating the Effectiveness of an In-home Self-management Intervention to Prevent Psychological Distress in Frail Older People Living in the Community
Brief Summary	The main objectives of this study are: 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, 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 an economical evaluation on the impact of the program on healthcare utilization and related costs.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Concerns About Falling Aged
Intervention ^ICMJE	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.
Study Arm (s)	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
Publications *	Dorresteijn TA, Rixt Zijlstra GA, Van Eijs YJ, Vlaeyen JW, Kempen GI. Older people's preferences regarding programme formats for managing concerns about falls. Age Ageing. 2012 Jul;41(4):474-81. Epub 2012 Feb 23. Dorresteijn TA, Zijlstra GA, Delbaere K, van Rossum E, Vlaeyen JW, Kempen GI. Evaluating an in-home multicomponent cognitive behavioural programme to manage concerns about falls and associated activity avoidance in frail community-dwelling older people: Design of a randomised control trial [NCT01358032]. BMC Health Serv Res. 2011 Sep 20;11:228.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	389
Completion Date	May 2011
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	70 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT01358032
Other Study ID Numbers ^ICMJE	MEC 07-3-064, ZonMw 120610001
Has Data Monitoring Committee	Yes
Responsible Party	Maastricht University Medical Center
Study Sponsor ^ICMJE	Maastricht University Medical Center
Collaborators ^ICMJE	ZonMw: The Netherlands Organisation for Health Research and Development
Investigators ^ICMJE	Not Provided
Information Provided By	Maastricht University Medical Center
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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