Accidental FallsNCT04161625
Evaluation of Reach, Effects and Cost Effectiveness of a Fall Preventive Intervention Including a mHealth Application
A study testing Digital exercise program with support in people with Accidental Falls, run by Umeå University at 1 site in Sweden.
Trial summary
The purpose is to evaluate reach, effects and costs effectiveness of a mobile, fall prevention exercise program for older community-dwelling persons (70+ years) in a pragmatic trial. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Digital exercise program with support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteSweden
- Study dates
- 14 Oct 2019to 13 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 70 years or older
- Have fallen or experienced a decline in perceived postural balance during the last year
- Have access to a smartphone or a tablet and uses it regularly
- Have an own email address and uses it
- Ability to understand verbal and written instructions in Swedish
- Can rise from a standard height chair without a person helping
- Independently mobile without a walking aid indoors
Who cannot join
- Progressive disease where there is likely to be a decline in strength or balance over the next year
- Perceived memory dysfunction that affect everyday life activities
- Taking part in more than 3 hours each week of strenuous physical exercise which makes them out of breath (e.g. dance, gymnastics, gym exercises, running or skiing)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose is to evaluate reach, effects and costs effectiveness of a mobile, fall prevention exercise program for older community-dwelling persons (70+ years) in a pragmatic trial.
Information about the study will be spread to the population by letters sent to all households with someone aged 70 years or older, presentations for senior organizations, advertisements on busses, health care centers, senior centers and in social media. Participants will be recruited in one municipality through the website (www.ostersund.se/sakrasteg) including information about the aim and procedures of the study. If seniors themselves judge that they are eligible to participate in the study, they can register by providing their email address. After baseline assessment, through self-reports in a digital survey, participants will get access to the mobile health application. The estimated target group is 2600 persons. Recruitment will be ongoing for six months. The intervention is delivered through the Safe Step application, developed in co-creation with seniors and researchers. Safe Step provides a large repository of evidence-based balance and strength exercises in video formats alongside falls preventive information and advice. With the Safe Step app the user can compose an individualized exercise program suitable for their needs. To help the user adhere to the program a set of behaviour change techniques is provided by the program. The user can set their own goals, get reminders and positive feedback form a virtual physiotherapist, and follow their own progress. Advice on how to integrate the exercises into everyday activities is also offered. The participants will exercise on their own with the help of the application for one year, with a recommendation of 30 minutes at least 3 times/week. In addition, participants will get monthly emails with falls preventive information in short videos, they will also be asked to report any falls by responding to a survey attached to the message.
Read more
In order to maximize reach and to support participants to get started using the Safe Step application, technical support and group-based exercise will be provided.
The interventions will last for 1 year with follow up assessments at 3, 6, 9, and 12 months in addition to the monthly fall reports. Effects and cost effectiveness will be evaluated in relation to a previously registered RCT NCT03963570.
- Conditions
- Accidental Falls
- Being tested
- Digital exercise program with support
- Keywords
- Prevention and control, Exercise therapy/methods*, Aged 70 and over, Smartphone, Computers handheld, Motivation, Behaviour change, Postural balance, Health behaviour, mHealth, eHealth, Digital health, Self-management, Re-aim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital exercise program with supportBehavioural
The Safe Step application includes an instruction movie on how to create and progress an individual exercise program. The exercises, presented in video format, are organized into 10 groups with a main focus on balance (3 groups), lower-limb strength (4 groups), and gait/step (3 groups). The participants choose an exercise suitable for their needs from each group to compose a program of ten exercises.
Participants use the app to plan their exercises, set reminders, register their exercise, and view statistics. A virtual physiotherapist delivers motivational messages and feed-back. At the end of each month the participants receive an email asking them to report any falls during the past month in a short digital survey. These messages also contains a new video with general falls prevention information.
Technical support will be provided weekly at senior meeting sites. Try-out group exercises (step 1-3) will be provided by a local wellness association (Friskis\&Svettis)
| Study group | Role | What they receive |
|---|---|---|
| Safe Step - digital exercise program | Experimental | All included participants will receive full access to the Safe Step application and create their own individual program of strength and balance exercises. During 1 year the participants are recommended to exercise at least 30 minutes, 3 times a week and continuously progress their program. In addition they will every month receive an email with general falls prevention information in a short video.
Additional support to promote reach and exercise adherence will be provided in the format of technical support and try-out group exercises throughout the recruitment period. Receives: Behavioral: Digital exercise program with support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach
The number of participants in relation to estimated size of total target population
Measured: 12 months
Secondary outcomes (24)
Sociodemographic characteristics age
Reach of recruitment will be assessed in relation to age.
Measured: Baseline
Sociodemographic characteristics gender
Reach of recruitment will be assessed in relation to gender.
Measured: Baseline
Sociodemographic characteristics living conditions
Reach of recruitment will be assessed in relation to living conditions).
Measured: Baseline
Functional leg strength
Self-administered chair stand test (i.e. number of stands during 30 seconds).
Measured: [Time Frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months]
Perceived Exertion
The Borg Scale of Perceived Exertion during the 30 second chair stand test, rated on a scale between 6 (none) to 20 (maximal exertion).
Measured: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Self-rated balance
Answering the question: "How do you perceive you balance?" on a 5-level ordinal scale ranging from "very good" to "very bad".
Measured: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Self-rated leg-strength
Answering the question: "How do you perceive your leg muscle strength?" on a 5-level ordinal scale ranging from "very good" to "very bad".
Measured: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Falls efficacy
Falls Efficacy Scale-International (FES-I). Concerns about falling is rated for 16 activities (e.g. cleaning the house) on a scale from 1 (not at all concerned ) to 4 (very concerned ). Ratings for each of the 16 activities are summed to a total score ranging from 16 (no concern about falling) to maximum 64 (severe concern about falling)
Measured: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Health related quality of life
Health related quality of life is assessed by the EuroQol 5 dimension 5 level self-report questionnaire (EQ-5D-5L).
The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and a Visual Analogue scale (VAS). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. A 1-digit number express the level selected for each dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. It should be noted that the numerals 1-5 have no arithmetic properties. The VAS records the respondent's self-rated health on a vertical, visual analogue scale (ranging from 0-100) with endpoints labelled "the best health you can imagine" and "the worst health you can imagine".
Measured: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Use of the information videos
Answering the question: "Have you watched the videos we sent you by e-mail during the last 3 months?" on a 4-level ordinal scale.
Measured: 3 months, 6 months, 9 months, 12 months
Experienced positive effects of the exercise intervention
Exercise intervention: Self-report of any positive effects of the exercise intervention besides effects on balance and strength. On a nominal scale including an optional text field.
Measured: 3 months, 6 months, 9 months, 12 months
Experienced negative effects of the exercise intervention
Exercise intervention: Self-report of any negative effects (adverse events) of the exercise intervention besides effects on balance and strength. On a nominal scale including an optional text field.
Measured: 3 months, 6 months, 9 months, 12 months
Physical activity
Self-reported minutes/week, pre-defined alternatives in 30 minutes blocks up to more than 2 hours.
Measured: Change: Baseline, 12 months
Exercise adherence throughout the intervention
Adherence to predefined minutes of 3x30 min/week reported continuously through an integrated exercise diary in the Safe step application and by self-report at follow up assessments.
Measured: 12 months
Self-rated improvements in balance
Answering the question: "If you compare with when you started this study a year ago, how would you assess balance today?" on a 5-level ordinal scale on a 5-level ordinal scale ranging from "much better" to "much worse".
Measured: 12 months
Self-rated improvements in leg-strength
Answering the questions: "If you compare with when you started this study a year ago, how would you assess the muscle strength in your legs today?" on a 5-level ordinal scale ranging from "much better" to "much worse".
Measured: 12 months
Rate of attrition
Drop-outs and with-draws in the study
Measured: 12 months
New exercise routines
Participants will be asked if they have started to do any exercises (besides the study intervention) during the intervention period.
Measured: 12 months
Costs related to the interventions
Participants will be asked to report if they have had any cost related to the intervention during the intervention period e.g. for internet access or equipment.
Measured: 12 months
Cost-effectiveness
Cost per falls averted, cost per quality adjusted life years gained.
Measured: 12 months
Participation in technical support sessions
Number of participants participating in technical support sessions
Measured: 12 months
Participation in try-out group exercises
Number of participants participating in try-out group exercise sessions
Measured: 12 months
Fall rate
Falls will be registered every month through a short digital survey, received by email, asking the participant if they had any falls during the last month. If answering yes a few additional questions about when the fall occurred, any resulting injuries and hospital visits will be asked.
Measured: 12 months
Number of fallers
Falls will be registered every month through a short digital survey, received by email, asking the participant if they had any falls during the last month. If answering yes a few additional questions about when the fall occurred, any resulting injuries and hospital visits will be asked.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start14 Oct 2019
- Primary completion13 Apr 2021
- Study completion13 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pragmatic clinical trial evaluating reach, effects and cost effectiveness of a mobile health application. The intervention will last for 12 months with follow-up assessments at 3, 6, 9 and 12 months.
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlene Sandlund, Ass Prof, Principal investigator, Umeå universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161625
- Sponsor's protocol ID
- SafeStepReach
- Status last verified
- Sep 2021
- First submitted
- 9 Oct 2019
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available from the corresponding author on reasonable request.
Publications
Bajraktari S, Zingmark M, Pettersson B, Rosendahl E, Lundin-Olsson L, Sandlund M. Reaching Older People With a Digital Fall Prevention Intervention in a Swedish Municipality Context-an Observational Study. Front Public Health. 2022 Apr 25;10:857652. doi: 10.3389/fpubh.2022.857652. eCollection 2022.
PubMed 35548075
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Reach, Effects and Cost Effectiveness of a Fall Preventive Intervention Including a mHealth Application
- ClinicalTrials.gov ID
- NCT04161625
- Acronym / sponsor ID
- SafeStepReach
- Conditions
- Accidental Falls
- Keywords
- Prevention and control, Exercise therapy/methods*, Aged 70 and over, Smartphone, Computers handheld, Motivation, Behaviour change, Postural balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 13 Apr 2021 (actual)
- Study completion
- 13 Apr 2021 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to evaluate reach, effects and costs effectiveness of a mobile, fall prevention exercise program for older community-dwelling persons (70+ years) in a pragmatic trial.
Information about the study will be spread to the population by letters sent to all households with someone aged 70 years or older, presentations for senior organizations, advertisements on busses, health care centers, senior centers and in social media. Participants will be recruited in one municipality through the website (www.ostersund.se/sakrasteg) including information about the aim and procedures of the study. If seniors themselves judge that they are eligible to participate in the study, they can register by providing their email address. After baseline assessment, through self-reports in a digital survey, participants will get access to the mobile health application. The estimated target group is 2600 persons. Recruitment will be ongoing for six months. The intervention is delivered through the Safe Step application, developed in co-creation with seniors and researchers. Safe Step provides a large repository of evidence-based balance and strength exercises in video formats alongside falls preventive information and advice. With the Safe Step app the user can compose an individualized exercise program suitable for their needs. To help the user adhere to the program a set of behaviour change techniques is provided by the program. The user can set their own goals, get reminders and positive feedback form a virtual physiotherapist, and follow their own progress. Advice on how to integrate the exercises into everyday activities is also offered. The participants will exercise on their own with the help of the application for one year, with a recommendation of 30 minutes at least 3 times/week. In addition, participants will get monthly emails with falls preventive information in short videos, they will also be asked to report any falls by responding to a survey attached to the message.
In order to maximize reach and to support participants to get started using the Safe Step application, technical support and group-based exercise will be provided.
The interventions will last for 1 year with follow up assessments at 3, 6, 9, and 12 months in addition to the monthly fall reports. Effects and cost effectiveness will be evaluated in relation to a previously registered RCT NCT03963570.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pragmatic clinical trial evaluating reach, effects and cost effectiveness of a mobile health application. The intervention will last for 12 months with follow-up assessments at 3, 6, 9 and 12 months.
| Arm | Type | Receives |
|---|---|---|
| Safe Step - digital exercise program | Experimental | Behavioral: Digital exercise program with supportAll included participants will receive full access to the Safe Step application and create their own individual program of strength and balance exercises. During 1 year the participants are recommended to exercise at least 30 minutes, 3 times a week and continuously progress their program. In addition they will every month receive an email with general falls prevention information in a short video. Additional support to promote reach and exercise adherence will be provided in the format of technical support and try-out group exercises throughout the recruitment period. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 70 years or older
- Have fallen or experienced a decline in perceived postural balance during the last year
- Have access to a smartphone or a tablet and uses it regularly
- Have an own email address and uses it
- Ability to understand verbal and written instructions in Swedish
Key exclusion criteria (3 listed)
- Progressive disease where there is likely to be a decline in strength or balance over the next year
- Perceived memory dysfunction that affect everyday life activities
- Taking part in more than 3 hours each week of strenuous physical exercise which makes them out of breath (e.g. dance, gymnastics, gym exercises, running or skiing)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital exercise program with supportThe Safe Step application includes an instruction movie on how to create and progress an individual exercise program. The exercises, presented in video format, are organized into 10 groups with a main focus on balance (3 groups), lower-limb strength (4 groups), and gait/step (3 groups). The participants choose an exercise suitable for their needs from each group to compose a program of ten exercises. Participants use the app to plan their exercises, set reminders, register their exercise, and view statistics. A virtual physiotherapist delivers motivational messages and feed-back. At the end of each month the participants receive an email asking them to report any falls during the past month in a short digital survey. These messages also contains a new video with general falls prevention information. Technical support will be provided weekly at senior meeting sites. Try-out group exercises (step 1-3) will be provided by a local wellness association (Friskis\&Svettis) | Behavioural | Safe Step - digital exercise program |
Primary outcome
Reach
Time frame: 12 months
The number of participants in relation to estimated size of total target population
24 secondary outcomes
Sociodemographic characteristics age
Time frame: Baseline
Sociodemographic characteristics gender
Time frame: Baseline
Sociodemographic characteristics living conditions
Time frame: Baseline
Functional leg strength
Time frame: [Time Frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months]
Perceived Exertion
Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Self-rated balance
Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Self-rated leg-strength
Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Falls efficacy
Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Health related quality of life
Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
Use of the information videos
Time frame: 3 months, 6 months, 9 months, 12 months
Experienced positive effects of the exercise intervention
Time frame: 3 months, 6 months, 9 months, 12 months
Experienced negative effects of the exercise intervention
Time frame: 3 months, 6 months, 9 months, 12 months
Physical activity
Time frame: Change: Baseline, 12 months
Exercise adherence throughout the intervention
Time frame: 12 months
Self-rated improvements in balance
Time frame: 12 months
Self-rated improvements in leg-strength
Time frame: 12 months
Rate of attrition
Time frame: 12 months
New exercise routines
Time frame: 12 months
Costs related to the interventions
Time frame: 12 months
Cost-effectiveness
Time frame: 12 months
Participation in technical support sessions
Time frame: 12 months
Participation in try-out group exercises
Time frame: 12 months
Fall rate
Time frame: 12 months
Number of fallers
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Derived from this study: PubMed 35548075Bajraktari S, Zingmark M, Pettersson B, Rosendahl E, Lundin-Olsson L, Sandlund M. Reaching Older People With a Digital Fall Prevention Intervention in a Swedish Municipality Context-an Observational Study. Front Public Health. 2022 Apr 25;10:857652. doi: 10.3389/fpubh.2022.857652. eCollection 2022.
- Individual participant dataSharing planned: Yes. Data will be available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlene Sandlund, Ass Prof principal investigator
Umeå universitet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital exercise program with support in people with Accidental Falls, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04161625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.