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Completed

NCT Number: NCT04161625

Evaluation of Reach, Effects and Cost Effectiveness of a Fall Preventive Intervention Including a mHealth Application

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.

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Key information

Conditions

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caring Science Buildning, Umeå University

Umeå, 90187, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Digital exercise program with support

Behavioral

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)

Primary outcomes

  1. Reach

    Time frame: 12 months

    The number of participants in relation to estimated size of total target population

Secondary outcomes

  1. Sociodemographic characteristics age

    Time frame: Baseline

    Reach of recruitment will be assessed in relation to age.

  2. Sociodemographic characteristics gender

    Time frame: Baseline

    Reach of recruitment will be assessed in relation to gender.

  3. Sociodemographic characteristics living conditions

    Time frame: Baseline

    Reach of recruitment will be assessed in relation to living conditions).

  4. Functional leg strength

    Time frame: [Time Frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months]

    Self-administered chair stand test (i.e. number of stands during 30 seconds).

  5. Perceived Exertion

    Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months

    The Borg Scale of Perceived Exertion during the 30 second chair stand test, rated on a scale between 6 (none) to 20 (maximal exertion).

  6. Self-rated balance

    Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months

    Answering the question: "How do you perceive you balance?" on a 5-level ordinal scale ranging from "very good" to "very bad".

  7. Self-rated leg-strength

    Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months

    Answering the question: "How do you perceive your leg muscle strength?" on a 5-level ordinal scale ranging from "very good" to "very bad".

  8. Falls efficacy

    Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months

    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)

  9. Health related quality of life

    Time frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months

    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".

  10. Use of the information videos

    Time frame: 3 months, 6 months, 9 months, 12 months

    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.

  11. Experienced positive effects of the exercise intervention

    Time frame: 3 months, 6 months, 9 months, 12 months

    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.

  12. Experienced negative effects of the exercise intervention

    Time frame: 3 months, 6 months, 9 months, 12 months

    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.

  13. Physical activity

    Time frame: Change: Baseline, 12 months

    Self-reported minutes/week, pre-defined alternatives in 30 minutes blocks up to more than 2 hours.

  14. Exercise adherence throughout the intervention

    Time frame: 12 months

    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.

  15. Self-rated improvements in balance

    Time frame: 12 months

    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".

  16. Self-rated improvements in leg-strength

    Time frame: 12 months

    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".

  17. Rate of attrition

    Time frame: 12 months

    Drop-outs and with-draws in the study

  18. New exercise routines

    Time frame: 12 months

    Participants will be asked if they have started to do any exercises (besides the study intervention) during the intervention period.

  19. Costs related to the interventions

    Time frame: 12 months

    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.

  20. Cost-effectiveness

    Time frame: 12 months

    Cost per falls averted, cost per quality adjusted life years gained.

  21. Participation in technical support sessions

    Time frame: 12 months

    Number of participants participating in technical support sessions

  22. Participation in try-out group exercises

    Time frame: 12 months

    Number of participants participating in try-out group exercise sessions

  23. Fall rate

    Time frame: 12 months

    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.

  24. Number of fallers

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 13, 2019
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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