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

Aged Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358032
• Other study ID #: MEC 07-3-064
• Secondary ID: ZonMw 120610001
• Status: Completed
• Phase: N/A
• First received: May 17, 2011
• Last updated: July 9, 2012
• Start date: March 2009
• Est. completion date: May 2011

Study information

• Verified date: July 2012
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aged
• Concerns About Falling

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. doi: 10.1093/ageing/afs007. Epub 2012 Feb 23. — View Citation

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. doi: 10.1186/1472-6963-11-228. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concerns about falling	Falls Efficacy Scale International (FES-I)	baseline, 5 months and 12 months	No
Primary	avoidance of activities due concerns about falling	Falls Efficacy Scale International Avoidance Behaviour (FES-IAB)	baseline, 5 months and 12 months	No
Secondary	disability	Groningen Activity Restriction Scale (GARS)	baseline, 5 months and 12 months	No
Secondary	number of falls	Fall calendar	continuous registration during the course of the trial for a period of 1 year	No
Secondary	catastrophic beliefs about falling	Catastrophic beliefs about falling (CAFS)	baseline, 5 months and 12 months	No
Secondary	perceived consequences of falling	CoF - loss of functional independence subscale and damage to identity subscale	baseline, 5 months and 12 months	No
Secondary	perceived control over falling	Perceived control over falling (PCOF)	baseline, 5 months and 12 months	No
Secondary	mastery	Personal Mastery Scale	baseline, 5 months and 12 months	No
Secondary	feelings of anxiety	Subscale of the Hospital Anxiety and Depression Scale (HADS-A)	baseline, 5 months and 12 months	No
Secondary	symptoms of depression	Subscale of the Hospital Anxiety and Depression Scale (HADS-D)	baseline, 5 months and 12 months	No
Secondary	social support interactions	Social support interactions (SSL 12-I)	baseline, 5 months and 12 months	No
Secondary	health-related quality of life	SF-12 Health Survey	baseline, 5 months and 12 months	No

External Links

•   project information on ZonMw website