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Falls-prevention in Older People Receiving Home-help Services

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ClinicalTrials.gov Identifier: NCT02374307
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Maria Bjerk, Oslo and Akershus University College of Applied Sciences

Brief Summary:
The aim of this study is to investigate the effect of a falls-prevention program on quality of life, fear of falling, falls and physical function in older people receiving home-help services. The participants in the intervention group will perform the Otago exercise programme. The participants in the control group continue with their usual activities.

Condition or disease Intervention/treatment Phase
Accidental Falls Other: Exercise and education Not Applicable

Detailed Description:
Falls and falls-related injuries are considered a serious public health issue in the older population. Strength and balance exercise in combination with information about falls prevention seems to be effective in reducing falls, but less is known about the effect of this kind of intervention on quality of life. Previous studies have shown that older people living at home and receiving home-help services seem to be at high risk of falling. We will therefore conduct a randomized controlled trial to investigate the effect of a falls prevention program on quality of life, fear of falling, falls and physical function in community-dwelling older people who receive home-help services. In addition, the cost-effectiveness of the intervention will be assessed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effect of a Falls-prevention Program on Quality of Life in Older People Receiving Home-help Services. A Randomized Controlled Clinical Trial
Actual Study Start Date : February 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise and education
This group will perform a 12-week individual tailored home exercise programme in accordance with the manual of Otaga exercise programme. Physiotherapist will visit the participants 5 times during the 12 weeks (at week 1,2,4,8 and 10) to prescribe and progress exercises. Motivational conversations on telephone will be performed the weeks when no visits are scheduled. Additionally, the participants will receive information on the first visit which will focus on motivation, importance of adherence and effectiveness of falls prevention. The participants are expected to do exercises on their own, and in that way perform exercises 3 times weekly. If safe, the participant will be provided with a walking plan and be encouraged to walk twice weekly.
Other: Exercise and education
Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.

No Intervention: Control
The control group will perform activities as usual.



Primary Outcome Measures :
  1. Changes in Health-related quality of life [ Time Frame: baseline, 3 months, 6 months and 12 months ]
    Changes in health-related quality of life will be measured with the SF-36 which is a questionnaire of 36 items. The 36 items are grouped into eight health status scales: physical functioning, role limitations due to physical problems and due to emotional problems, bodily pain, general health perception, vitality, social functioning and mental health.


Secondary Outcome Measures :
  1. Number of falls [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]
    Falls will be defined as an event, i.e. fall, trip, slip, which results in the person coming to rest on the ground or floor or other lower level, and the participant will be asked: "Have you had any fall including slip or trip in which you lost your balance and landed on the floor or ground or lower level?". This registration will be performed on monthly calendars which will be collected every third month.

  2. Ability to perform activities of daily living. [ Time Frame: baseline, 3 months and 6 months ]
    ADL will be registered with Lawton & Brody ADL scales, which are valid and reliable measures of a person's self-reported ability to perform both basic and complex activities of daily living .

  3. Falls-efficacy (Falls Efficacy Scale-International) [ Time Frame: baseline, 3 months and 6 months ]
    Falls-efficacy will be measured with the Falls Efficacy Scale-International, a self-report questionnaire of 16 items measuring level of concern about falling during 16 activities of daily living. Minimum score 16, maximum score 64.

  4. Health- related quality of life measured by the EQ-5D [ Time Frame: baseline, 3 months, 6 months and 12 months ]
    The EQ-5D-5L is a generic and validated questionnaire. It describes five dimensions of HRQL (mobility, self-care, usual activities, pain/discomfort, anxiety depression) each of which can take one of five responses at five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems).

  5. Physical activity level (questions regarding walking habits) [ Time Frame: baseline, 3 months and 6 months ]
    Questions regarding walking habits in the last 7 days.

  6. Amount of home-help services received [ Time Frame: baseline, 3 months, 6 months, 12 months ]
  7. Basic nutritional status (Mini Nutritional Assessment) [ Time Frame: baseline, 3 months and 6 months ]
    The first section of the Mini Nutritional Assessment, containing questions on nutrition and weight and measurement of BMI, will be used.

  8. 4 meter gait speed [ Time Frame: baseline, 3 months and 6 months ]
    Participants are asked to walk a distance of 4 meters at their usual pace

  9. 30 seconds chair stand test [ Time Frame: baseline, 3 months and 6 months ]
    From the sitting position, the subject stands completely up, then completely back down, and this is repeated for 30 seconds.

  10. Adherence to the programme [ Time Frame: 3 months ]
    Participant will complete an activity diary where they note if the programme has been executed. If they have not completed sufficient exercise they will note why not.

  11. Berg Balance Scale [ Time Frame: baseline, 3 months and 6 months ]
    BBS measures static and dynamic balance. It comprises a set of 14 balance related tasks.



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Ages Eligible for Study:   67 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • has fallen at least one time in the last 12 months
  • receives home-help services
  • able to walk independently indoors with or without walking aid

Exclusion Criteria:

  • medical contraindication to exercise
  • life expectancy <1 year
  • scores under 23 points on Mini Mental Scale Examination
  • participating in another falls prevention programme during the 12 weeks of the programme, for example a falls prevention group

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374307


Locations
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Norway
Municipality of Frogn
Drøbak, Akershus, Norway
Municipality of Rælingen
Fjerdingby, Akershus, Norway
Municipality of Skedsmo
Lillestrøm, Akershus, Norway
Municipality of Lørenskog
Lørenskog, Akershus, Norway
Municipality of Bærum
Sandvika, Akershus, Norway
Municipality of Sørum
Sørumsand, Akershus, Norway
Sponsors and Collaborators
Oslo and Akershus University College of Applied Sciences
Investigators
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Study Director: Astrid Bergland, PhD Oslo and Akershus University College of Applied Sciences
Principal Investigator: Maria Bjerk, MSc Oslo and Akershus University College of Applied Sciences

Additional Information:
Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Bjerk, PhD Research Fellow, Oslo and Akershus University College of Applied Sciences
ClinicalTrials.gov Identifier: NCT02374307     History of Changes
Other Study ID Numbers: 2014/2051
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maria Bjerk, Oslo and Akershus University College of Applied Sciences:
Falls
home-care services
older people
falls-prevention