Table 1.
Data category | Information |
Primary registry and trial identifying number | ISRCTN:12 830 220 |
Date of registration in primary registry | 21.08.2018 |
Secondary identifying numbers | |
Source of monetary or material support | National Institute for Health Research Postdoctoral Fellowship Award |
Primary sponsor | University of Manchester |
Secondary sponsor | N/A |
Contact for public queries | Helen.hawley-hague@manchester.ac.uk |
Contact for scientific queries | Helen.hawley-hague@manchester.ac.uk |
Public title | The TOGETHER trial |
Scientific title | Can smartphone technology be used to support an effective home exercise intervention to prevent falls among community dwelling older people? The TOGETHER feasibility RCT |
Countries of recruitment | UK |
Health condition of problem studied | Falls in older adults |
Interventions |
Standard service:
Manchester City: 12 weeks once a week contact (home or group exercise), check-ups until 6 months discharge. Trafford: 8-week group exercise once a week or 6-week home exercise then discharged or referred to further 8-week group exercise. Control: For all prescribed exercise plan and exercise booklet given, asked informally what they want to achieve (outcome goals). Use of study provided smartphone for reporting exercises and falls detection as outcome measures only Intervention: standard service (as above) plus the use of ‘Motivate me’ (health professional app) and ‘My activity programme’ (patient app) on study provided smartphones. |
Key inclusion and exclusion criteria |
Age: older adults aged 50+ Sex: male or female Inclusion: at risk of falls, referred to falls rehabilitation services and assessed as suitable for an exercise programme, good 3G/4G reception in their home or wifi. Exclusion: unable to follow instructions (unless they have support from a family member or carer), Severe visual impairment, long-term residential or nursing care, terminal illness or expected shortened lifespan, defined as less than 6 months, older adults unable to read written English unless they have support from a family member or carer). |
Study type | Interventional Allocation: randomised; Primary purpose: prevention, feasibility |
Date of first enrolment: | 20th September 2018 |
Target sample size | 72 |
Recruitment status | Pending |
Primary outcome | Feasibility of the design and procedures |
Key secondary outcomes | Balance (Berg), function (TUG/mTUG), falls (calendar/FallsMonitor@home), strength (30 s chair stand), fear of falling (Short FES-I), health-related quality of life (EQ-5D-5L/ ICE-CAP-O), resource use, adherence (my activity programme/EARS). Baseline, 3, 6 months. |
EARS, Exercise Adherence Rating Scale; EQ-5D-5L, European Quality of Life 5 Dimensions; FES-I, Falls Efficacy Scale-International; ICE-CAP-O, ICEpop CAPability measure for Older people; ISRCTN, International Standard Randomised Controlled Trials Number; mTUG, Mobile based instrumented timed up and go test; TUG, timed up and go test.