Condition category
Not Applicable
Date applied
06/05/2009
Date assigned
17/06/2009
Last edited
17/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.bedrebalance.dk

Contact information

Type

Scientific

Primary contact

Dr Carsten Hendriksen

ORCID ID

Contact details

Department og Integrated Health Care
Bispebjerg University Hospital
Bispebjerg Bakke 23
Copenhagen NV
2400
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised controlled trial to test the effects of, respectively, health coaching and an integrative district nurse approach for preventing falls in elderly people living in the community

Acronym

Study hypothesis

Health coaching and integrative district nurse approaches (two separate interventions) tailored to elderly people having experienced fall accidents and living in the community are, compared to usual care control groups, both expected to:
1. Reduce the rate of falls (primary endpoint), measured by self-evaluation and registered hospital admissions
2. Reduce the risk of falling, measured by selected functional tests
3. Reduce the use of selected primary care services

Ethics approval

Scientific Ethics Committee of Copenhagen, Denmark gave approval on the 13th April 2007 (ref: H-C-2007-0002)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Fall prevention, elderly people living in the community

Intervention

1. Health coaching program: 6 months collaboration with professional health coach; maximum of 10 hours of coaching, maximum of 15 sessions in total, of which two are face-to-face meetings and the rest are telephone sessions
2. Integrative district nurse program: 3 months collaboration with district nurse; two face-to-face meetings in the home, followed by two telephone sessions

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Number of falls in a twelve months period from inclusion date, measured through self-assessment.

Secondary outcome measures

1. Functional performance nine months after inclusion. Selected balance and strengths tests indicating fall risks.
2. Fear of falling questionnaire (FES-I), quality of life questionnaire
3. Use of selected primary care services in a nine month period after inclusion (emergency calls, district healthcare, delivery of food, etc.,)
4. Hospital contacts in a nine month period after inclusion

Overall trial start date

01/05/2007

Overall trial end date

01/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Community-dwelling people aged 65+ years, either sex
2. Fall episodes registered/known by trial partners at Hospital Units and Community Units
3. Speaking Danish or English, no interpreter needed

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

One hundred and eighty (180) patients

Participant exclusion criteria

1. Participation in other clinical trials on falls prevention
2. Hospital admission due to the most recent fall accident (prior to inclusion)

Recruitment start date

01/05/2007

Recruitment end date

01/04/2009

Locations

Countries of recruitment

Denmark

Trial participating centre

Department og Integrated Health Care
Copenhagen NV
2400
Denmark

Sponsor information

Organisation

Danish Ministry of Health and Prevention (Ministeriet for Sundhed og Forebyggelse) (Denmark)

Sponsor details

Slotsholmsgade 10-12
Copenhagen K
1216
Denmark

Sponsor type

Government

Website

http://www.sum.dk

Funders

Funder type

Government

Funder name

Danish Ministry of Health and Prevention (Ministeriet for Sundhed og Forebyggelse) (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes