Table 3

List of assessments and outcome measures collected during telephone screening, risk screening, medical screening, baseline assessment, after 6 months active intervention and further 6 months passive follow-up

TSRSMST1T2T3O
Sociodemographic
 Age, gender, employment status, living arrangements (community-dwelling or residential aged care facility), number of cohabitants, years of education✓–
 Economic satisfaction (good, sufficient, bad/poor)✓–
 Prior experience with using smartphone technology (yes/no)✓–
General health and function
 Ability to walk 500 m without walking aid✓–
 Ability to read newspaper in print and on a smartphone✓–
 Participation in an organised exercise group >1 per week (yes/no)✓✓✓S
 Currently undertaking 150 min or more in moderate-intensity PA per week (yes/no)✓✓✓S
 Amount of moderate-intensity PA undertaken per week (hardly active; mostly seated activities; light-intensity PA (2–4 hours/week); moderate-intensity PA (1–2 hours/week) or light-intensity PA (>4 hours/week); moderate-intensity >3 hours/week; high-intensity PA several times per week)✓✓✓S
 Late-Life Function and Disability Instrument (LLFDI) to assess meaningful change in function (person’s ability to do discrete actions/activities) and disability (person’s performance of socially defined tasks)30 31✓✓✓P
Medical history and medication use
 ‘Have you seen a doctor for being diagnosed for having problems with your joints?’*✓✓✓–
 ‘Have you seen a doctor for being diagnosed for having problems with your heart?’†✓✓✓–
 Medications used (total number, type, frequency, dosage)✓✓✓✓S
 Fall history (count over last 12 months)✓✓✓S
 Pain during rest and walking (numeric scale, score 0–10)41✓✓✓S
 Blood pressure (mm Hg) in lying and standing (after 1 and 3 min); pulse, vision, hearing✓–
 Comorbidities (number, type, date of diagnosis and treatment)✓–
 Height (cm), weight (kg)✓–
 Regular alcohol consumption per week (units)✓–
Neuropsychological
 Center for Epidemiologic Studies Depression Scale (CES-D) score to assess symptoms of depression and mood (score range 0–60)‡42✓✓✓S
 7-Item Short Version Falls Efficacy Scale-International (FES-I) (score)43 plus three additional FES-I items to assess ‘fear of falling’‡44✓✓✓S
 Montreal Cognitive Assessment (MoCA) tool (converted MoCA score) to assess cognitive function (score _/30)‡29✓✓✓S
Physical
 Gait speed over 4 m (usual pace)45 and 7 m (usual pace and as fast as possible)46 (best of two trials per measure, m/s)✓§✓✓✓S
 Hand grip strength using a dynamometer (kg, max score of 3 reps per hand, using the protocol of the InChianti study)✓✓✓–
 Five times sit-to-stand to assess functional strength45✓✓S
Physical—balance
 Able to perform ‘Tandem stance’ for 10 s with eyes open (yes/no)✓S
 Community Balance and Mobility Scale (CB&MS) used to measure higher level balance and mobility47✓✓✓S
 Static balance measured using the 8-Level Balance scale18✓✓✓S
 Physical—instrumented (participants have a smartphone attached to their lower back, instructions are provided by the assessor. Activity is recorded for the duration of the assessment)
 30 s chair stand is completed to quantify strength35✓✓✓S
 Timed Up and Go33 to measure sit-to-stand duration and movement jerk, mean step time, variability of step time, interstride trunk sway in anterior-posterior and mediolateral directions34✓✓✓S
 Tandem stance, 30 s, eyes closed, to assess sway in anterior-posterior and mediolateral directions✓✓✓S
 Five times sit-to-stand to quantify strength and measure sit-to-stand duration✓S
 Physical—self-administered (instructions are provided in written form (paper and smartphone) and acoustic cues are provided through the smartphone)
 Timed Up and Go33 is completed to measure sit-to-stand duration and movement jerk, mean step time, variability of step time, interstride trunk sway in anterior-posterior and mediolateral directions34✓✓S
 Tandem stance, 15 s, eyes closed, to assess sway in anterior-posterior and mediolateral directions✓S
 Tandem stance, 15 s, eyes open, to assess sway in anterior-posterior and mediolateral directions✓S
 Five times sit-to-stand to quantify strength and measure sit-to-stand duration✓✓S
Physical—sensor-derived data
 Behavioural complexity of PA and sleep measured through activity monitoring (data collection for 7 continuous days) (type, duration, intensity)✓✓✓P
 Physical activity39 (a set of sensor-based features extracted from signals, including the percentages of sedentary, active and walking times, duration and intensity (metabolic equivalent) of the activities, and gait and turning characteristics)✓✓✓S
Health economics/quality of life
 EuroQol-5D, EQ-5D-5L to measure quality of life and as a utility-based quality of life instrument will be used for estimating QALYs (descriptive profile and a single index value for health-related quality of life)48✓✓✓S
 12-Item Short Form (SF-12) survey to measure function and well-being/quality of life49✓✓✓S
 A resource-use questionnaire is used to ascertain health resource utilisation (eg, GP visits, medication use and healthcare cost from a societal perspective)✓✓✓S
Adherence (monthly follow-up during active and passive intervention period)
 Number of visits/calls successfully completed during the intervention periodS
 Withdrawals from intervention (n)S
 PreventIT mHealth system use after 6 months (eLiFE only)S
 Uptake and adherence to recommendations/LiFE (all three intervention arms, monthly question) was assessed via email (by use of a secure web-based form) or post including one reminder. ‘Over the last seven days, did you perform the recommended level of physical activity?’ The response options are as follows: (1) yes, I did more than I planned; (2) yes, I did them all; (3) yes, but not as much as I intended; (4) no, I did not feel well; (5) no, I forgot; (6) no, I did not have time; (7) no, I do not like these activities. The control group’s response is identical to the options from the active arm, except the generic term ‘physical activity’ is used instead of ‘activities’.S
 Adherence to the recommendations/LiFE (all three intervention arms, at post-test and follow-up) and validation of the monthly adherence questions will be evaluated by use of the Exercise Adherence Ratio Scale (EARS)50✓✓S
Experience, motivation and behavioural change
 Self-Reported Behavioural Automaticity Index to assess habit formation (score, 7-point Likert scale)51✓✓S
 Level of ease or difficulty in engaging with the intervention and integrating balance, strength and PA into everyday life (score, 7-point Likert scale)✓✓
 Motivational aspects of the intervention (score, 7-point Likert scale)✓✓S
Willingness to participate
 Recruitment numbers, dropouts (n), CONSORT (participant numbers through trial progression)
 Health Action Process Approach (HAPA) to measure participants’ motivation52✓✓✓S
Usability of technology (eLiFE only)
 The System Usability Scale53 at post-test and 12 months follow-up✓✓S
 The Telehealthcare Satisfaction Questionnaire–Wearable Technology (TSQ-WT)54 at post-test and 12 months follow-up✓✓S
 Issues logs from eLiFE participants will be summarised and described
 PreventIT mHealth system feasibility, adherence and progression✓✓S
 Usability technology (questionnaire)✓✓S
 Data from PreventIT mHealth system

  • PA sensors (daily distribution of walking, sedentary time and active intervals).

  • Daily reporting of activities (strength and balance goals achieved?).

  • Use of smartphone (number of phone calls, SMS, number of contacts, GPS location (STU and TRD only)).

  • Use of application (usage, changes in activity selection).

  • Difficulties with technology (via an issue log).

✓✓S
 Acceptability of the intervention✓S
 Focus groups (10 participants per intervention arm, at each site): qualitative analysis of narratives of experience of recruitment process, randomisation process, screening and assessments, home visits, instructors, tools used (paper-based or technology), support in intervention period, activities undertaken, ideas for improvement. Qualitative data will also be used to evaluate usability of technology.✓S
 Focus groups (with all assessors and instructors): qualitative analysis of narratives of recruitment process, training, successes and challenges in delivering intervention, ideas for improvement✓S
  Issue logs from the instructors will be evaluated related to acceptability from the instructors’ perspectives.S
 Acceptability questionnaire 55 with rating of helpfulness of aLiFE/eLiFE activities for improving balance, strength, PA; perceived safety during aLiFE/eLiFE practice; perceived level of difficulty, activity preference, adaptability of activities to fit individual lifestyles and daily activities✓✓S
 Adverse events—intervention related and unrelatedS

  • *Question is answered yes/no, and if ‘yes’, if any arthrosis, rheumatologic diseases, or other arthropathies or joint disorders are registered.

  • †Question is answered yes/no, and if ‘yes’, if any heart failure, myocardial infarction, cardiac dysrhythmias or arrest, valvular disease, or other ischaemic heart disease is registered, and if ‘no’, if any cerebrovascular disease or stroke, hypertension/high blood pressure, or peripheral artery disease is registered.

  • ‡Assessment is part of the risk screening and eligibility criteria, as well as being an outcome measure.

  • §Only 7 m walk at fast pace was assessed during the RS.

  • –, not an outcome measure; 6mth, assessment 6 months after randomisation; 12mth, assessment 12 months after randomisation; aLiFE, adapted LiFE; BA, baseline assessment; CONSORT, Consolidated Standards of Reporting Trials; eLiFE, enhanced LiFE; EQ-5D-5L, 5-level version of EuroQol-5 Dimension; GP, general practitioner; GPS, Global Positioning System; LiFE, Lifestyle-integrated Exercise programme; MS, medical screening; O, outcome measure; P, primary; PA, physical activity; QALY, quality-adjusted life-year; RS, risk screening; S, secondary; SMS, short message service; STU, clinical site Stuttgart, Germany; TRD, clinical site Trondheim, Norway; TS, telephone screening.