Falls prevention Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Current interventions as of 14/02/2018:
Main OTIS trial: Participants will be randomly allocated 2:1 in favour of the control group to receive either:
1. Usual care from their GP or other healthcare
or
2. One home environmental assessment and modification to identify personal fall related hazards by an occupational therapist, in addition to usual care and a falls prevention leaflet.
Up to 12 p
Sponsors
University of York (UK)
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 14/02/2018: Main OTIS study: 1. Aged 65 years and over 2. Willing to receive a home visit from an Occupational Therapist 3. Community dwelling 4. Have at least one risk factor for a fall in the next 12 months i.e., either one fall in the past 12 months or report a fear of falling on their screening questionnaire If a respondent is initially assessed as being ineligible because they have not had a fall within the past 12 months and do not report a fear of falling, but otherwise fulfil the eligibility criteria and consent to being re-contacted, they will be rescreened at a later date and given the opportunity to take part in the study if they subsequently have a fall or report a fear of falling and therefore, meet the inclusion criteria. OTIS qualitative study: Occupational Therapists delivering the OTIS intervention, clinical leads who run falls prevention services/care of older people services and services external to the trial will be eligible to be involved in the qualitative study. Pen sub-study: Any patient identified in the GP mail out as eligible to receive an OTIS trial invitation pack will be entered into the pen sub-study. Invitation letter sub-study: Participants who are due to be mailed out an invitation pack about the OTIS trial in the first mailout by the Yorkshire Health Study will be entered into the invitation latter sub-study. Text sub-study: Participants who provide a mobile phone number and consent to be contacted by this method, and who are due to be sent their four month follow-up questionnaire, will be included in this sub-study. Added 12/06/2020: Social incentive cover letter and/or pen sub-study: Any participant due to receive their 12-month questionnaire Previous inclusion criteria: Main OTIS study: 1. Aged 65 years and over 2. Willing to receive a home visit from an Occupational Therapist 3. Community dwelling 4. Have at least one risk factor for a fall in the next 12 months i.e., either one fall in the past 12 months or report a fear of falling on their screening questionnaire or be a former REFORM trial participant OTIS qualitative study: Occupational Therapists delivering the OTIS intervention, clinical leads who run falls prevention services/care of older people services and services external to the trial. Pen sub-study: Any patient identified in the GP mail out as eligible to receive an OTIS trial invitation pack will be entered into the pen sub-study. Text sub-study: Participants who provide a mobile phone number and consent to be contacted by this method, and who are due to be sent their four month follow-up questionnaire will be included in this sub-study.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 14/02/2018: Main OTIS trial: 1. Unable to walk 10 feet today, even with a walking aid if needed 2. Unable to give informed consent e.g., due to suffering from dementia or Alzheimer’s disease 3. Living in residential or nursing home 4. Unable to read or speak English and have no friend or relative who is able to translate/interpret for them 5. Had an OT assessment for falls prevention in the previous 12 months 6. Are on a waiting list for an occupation therapy assessment 7. Have not returned one completed falls calendar in the 3 months prior to randomisation Pen sub-study: Participants in the REFORM, CASPER and Yorkshire Health Study cohorts and the SCOOP study will be excluded from the sub-study. Text sub-study: Participants who withdraw from the OTIS main trial follow-up before their 4-month questionnaire is due will be excluded from this sub-study. Invitation letter sub-study: Participants who have not agreed to be contacted about future studies. Previous exclusion criteria: Main OTIS trial: 1. Unable to walk 10 feet today, with a walking aid if needed 2. Unable to give informed consent e.g., due to suffering from dementia or Alzheimer’s disease 3. Living in residential or nursing home 4. Do not speak English 5. Had a home assessment in the previous 12 months as a result of falling 6. Are on a waiting list for an occupation therapy assessment 7. Have not completed one falls calendar in the 3 months prior to randomisation Pen sub-study: Participants in the REFORM, CASPER and Yorkshire Health Study cohorts and the SCOOP study will be excluded from the sub-study. Text sub-study: Participants who withdraw from the OTIS main trial follow-up before their 4-month questionnaire is due will be excluded from the mail out.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 14/02/2018: Main OTIS trial: Number of falls experienced in the 12 months following randomisation, where a fall is defined as “an unexpected event in which the participant comes to rest on the ground, floor, or lower level”, as collected prospectively via participant-reported monthly falls calendars. Pen sub-study: The proportion of participants who go on to be randomised into the main OTIS trial. Invitation letter sub-study: The proportion of participants who go on to be randomised to the main OTIS trial. Text sub-study: The proportion of four-month questionnaires returned to the York Trials Unit. Added 12/06/2020: Social incentive cover letter and/or pen sub-study hypothesis: The primary outcome was response rate, defined as the proportion of participants in each group who returned the 12-month questionnaire. Previous primary outcome measures: Main OTIS trial: Number of falls experienced in the 12 months following randomisation, where a fall is defined as “an unexpected event in which the participant comes to rest on the ground, floor, or lower level”, as collected prospectively via participant-reported monthly falls calendars. Pen sub-study: The proportion of participants sent a trial invitation pack who go on to be randomised into the main OTIS trial. Text sub-study: The proportion of four-month questionnaires returned to the York Trials Unit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 14/02/2018: Main OTIS trial: 1. Health-related Quality of Life as measured by the EQ5D-5L at 4, 8 and 12 months 2. Proportion of participants reporting at least one fall in the 12 months from randomisation 3. Proportion of participants reporting multiple (2 or more) falls in the 12 months from randomisation 4. Time to first fall from date of randomisation, with censoring at date of withdrawal, death or end of 12 month follow-up 5. Fear of falling at 4, 8 and 12 months 6. Fall-related injuries and costs over the 12 months post randomisation 7. Patient self-reported fractures over the 12 months post randomisation Pen sub-study: 1. The proportion of participants who return a screening form 2. Time to return screening form 3. The proportion of participants who fulfil the eligibility criteria apart from the criterion relating to falls within the past 12 months or fear of falling 4. The proportion of participants eligible for randomisation 5. The proportion of participants who remain in the trial for 3 months post randomisation. Invitation letter sub-study: 1. The proportion of participants who return a screening form 2. Time to return screening form 3. The proportion of participants who fulfil the eligibility criteria apart from the criterion relating to falls within past 12 months or fear of falling 4. The proportion of participants who are eligible for randomisation 5. The proportion of participants who remain in the trial for 3 months post randomisation. Text message sub-study: 1. Time to response i.e. number of days between the questionnaire being mailed out to the participant and the questionnaire recorded as being returned to York Trials Unit 2. The proportion of participants requiring a reminder 3. Completeness of questionnaires 4. Cost effectiveness of the text message intervention Added 12/06/2020: Social incentive cover letter and/or pen sub-study: 1. Time to return 12-month questionnaire 2. The completeness o | — |
Countries
England, United Kingdom
Outcome results
None listed