None listed
Conditions
Brief summary
The aim of this study is to assess the effectiveness of a novel self-managed cognitive behavioural therapy program on concerns about falling with or without an additional graded balance program versus an online health education program with a focus on general health concerns relevant to older people. The primary outcome (concerns about falling) and secondary outcomes (balance confidence, depression, anxiety, activity avoidance, wellbeing, fall-related health literacy, physical activity, movement intensity, quality of life, exercise self-efficacy and falls) will be measured in the form of a randomised controlled trial. Ongoing exercise participation for both intervention groups beyond the 8-week program will be facilitated through the New South Wales Active and Healthy website to continue with a pandemic-safe exercise program.
Interventions
This randomised controlled trial will comprise of two intervention and one control group. One intervention group will receive the Own Your Balance program and one intervention group will receive the Own Your Balance program plus the StandingTall graded activity program – both delivered through a tablet or computer in people’s homes with limited therapist input over a period of 8 weeks. At the end of 8 weeks, both groups will receive individual guidance over the phone, using motivational interviewing techniques, to use the Active and Healthy website to continue with an exercise program (at least 2 hours of exercise each week) for the next 10 months. A follow-up call will be done at 12 weeks to see if the participants in both intervention groups have started with their exercise program. (i) The Own Your Balance program consists of two components, i.e. the online myCompass program and a workbook. The myCompass program offers 14 skill-building modules that cover a wide range of topics such as “Managing Fear and Anxiety”, “Taking Charge of Your Worry” and “Solving Problems”. Each module comprises 3x10min sessions. Participants will be asked to complete at least 3 modules during the 8-week program. Participants will also be given the Own Your Balance workbook to complete during the 8-week program which provides weekly psycho-education chapters on falls and concerns about falling. The content of the program is derived from Cognitive Behavioural Therapy, Interpersonal Psychotherapy, Problem-solving Therapy and Positive Psychology. There are home practice tasks for participants to complete (i.e. completion of one full module per week followed by 1 week of practice), which are intended to promote skill generalisation. Each chapter from the workbook will take approximately 15 minutes to complete. After the 8-week program, participants from both intervention groups can continue to use the Own Your Balance program. Participants will receive a 30-minute induction to myCompass via telehealth, during which they will be setup with the program and guided to use it. (ii) The graded activity balance program is the StandingTall program, which delivers personalised exercises that automatically increase in difficulty over time. It uses mobile technology to provide home-based unsupervised exercises with compliance-promoting features by providing feedback, goal-setting, monitoring and sending of reminders. The program comprises standing on an unsteady surface (e.g. a foam surface), transferring (e.g. sit-stand transitions), walking (e.g. walking in circles or to targets in a grid), stepping (e.g. step and lift) and box (e.g. step up and over a box) exercises. The StandingTall program offers an effective way for people to improve their balance and reduce their fall risk. The program starts with 40min of training in week 1, using a paced approach to sustainably build towards a weekly target of 120min from week 3 to 8. Participants will receive a 90-min induction to StandingTall via telehealth, during which they will be setup with the program and guided to safely use it. Ongoing exercise participation for both intervention groups beyond the 8-week program will be facilitated through the New South Wales Active and Healthy website (www.activeandhealthy.nsw.gov.au) to continue with a pandemic-safe exercise program. This website provides detailed descriptions of evidence-based exercise fall prevention classes and assists older people to find an appropriate exercise program that is available to them. - Following a baseline assessment, an exercise physiologist from the research team will conduct a teleconference with the intervention group participants. Participants receiving the Own Your Balance program will undertake a 30 minute setup call. Participants also receiving the StandingTall program will undertake an additional 90 minute setup call. - Both intervention groups will receive a weekly online health promotion education program with a focus on general health concerns (e.g. medications, blood pressure, healthy diet) relevant to older people. Participants will be asked to read the fact sheets weekly during the 8-week period. The program will be provided to the participants through a website with weekly updates. Adherence will be tracked automatically through the website. - One intervention group will receive the Own Your Balance program and one intervention group will receive Own Your Balance plus the StandingTall graded activity program – both delivered through a tablet computer. - StandingTall participants will receive additional instructions on how to perform the exercises safely. - Participant adherence (training duration and frequency) to the StandingTall program will be monitored following automatic data transfer to a server and examined weekly. Participants not engaging with the StandingTall program for two consecutive weeks will be contacted by telephone to discuss any issues pertaining adherence by the (unblinded) research assistant. - Further phone and email support will be available as needed for the duration of the study. A follow-up call will be done at 4 weeks for intervention group participants to see how they are progressing with the Own Your Balance program (i.e. myCompass and the workbook). At 12 weeks, another follow-up call will be given to see if the participants in both intervention groups have started with their exercise program. - Participants will be asked to use their own devices where possible and will be provided with the devices for the duration of the study if required.
Sponsors
Study design
Eligibility
Inclusion criteria
-65 years of age and older -has substantial concerns about falls or balance, as indicated by: •Are you concerned about falling or your balance? (self-rated as somewhat to extremely) •OR “Are you concerned about falling or your balance?” (self-rated as a little bit) and "somewhat to extremely" on any of the following questions (How concerned are you that you might fall when going up/down the stairs? How concerned are you that you might fall when walking on an uneven surface? How concerned are you that you might fall when taking a shower?) •AND/OR low balance confidence (self-rated as poor or fair) (How do you feel your balance is?) -able to walk household distances without a walking aid (self-reported) -living in the community (self-reported) -English-speaking (self-reported) -willing and able to give informed consent and comply with the study protocol
Exclusion criteria
-cognitive impairment (Short Portable Mental Status Questionnaire score <8) -severe depression or suicidal thoughts (Patient Health Questionnaire-9 score >=20 or scoring 3 on the last question) -acute psychiatric condition with psychosis (self-reported) -any medical condition that precludes exercise participation (self-reported) -progressive neurological condition such as Parkinson’s disease, Multiple Sclerosis, Alzheimer’s disease (self-reported) -currently participating in a fall prevention program (self-reported)