Table 1

WHO trial registration data set

Data categoryInformation
Primary registry and trial identifying numberISRCTN:12 830 220
Date of registration in primary registry21.08.2018
Secondary identifying numbers
Source of monetary or material supportNational Institute for Health Research Postdoctoral Fellowship Award
Primary sponsorUniversity of Manchester
Secondary sponsorN/A
Contact for public queriesHelen.hawley-hague@manchester.ac.uk
Contact for scientific queriesHelen.hawley-hague@manchester.ac.uk
Public titleThe TOGETHER trial
Scientific titleCan 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 recruitmentUK
Health condition of problem studiedFalls 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 typeInterventional
Allocation: randomised;
Primary purpose: prevention, feasibility
Date of first enrolment:20th September 2018
Target sample size72
Recruitment statusPending
Primary outcomeFeasibility of the design and procedures
Key secondary outcomesBalance (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.