main results of the istoppfalls randomized controlled trial · fall prevention and prediction...

Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015

Main Results of the iStoppFallsRandomized Controlled Trial

Rainer Wieching (University Siegen, Germany)on behalf of the iStoppFalls Consortium


iStoppFalls Funding & ConsortiumiStoppFalls - ICT based System to Predict & Prevent Falls

Consortium

Funding


iStoppFalls RCT iStoppFalls - ICT based System to Predict & Prevent Falls

Study Design

Objectives & Methods


ObjectivesiStoppFalls - ICT based System to Predict & Prevent Falls

Objectives

Assessing the feasibility and effects of an ICT-basedfall prevention and prediction system (iStoppFalls) in community-dwelling older adults (> 65 years ).

Primary Objectives:

1) Reduction of Fall Risk, 2) Improvement of Quality of Life

Secondary Objectives:

Physical, Cognitive, Health, Social and Technology Adherence, Usability, User Experience & Acceptance


Study DesigniStoppFalls - ICT based System to Predict & Prevent Falls

Study Design

Design: Multicenter randomized clinical trial in Europe & Australia

Study Centers: Cologne (n=60), Valencia (n=40), Sydney (n=60)

Participants:160 older adults (80 intervention, 80 control)

Inclusion criteria:Age 65+, Able to walk without aids; Independent Living, Internet Access, HDMI-TV

Exclusion criteria:Severe Diseases: Cardiovascular, Neurologic, Orthopedic, Cancer. Impaired Cognition (MiniCOG), and other severe disorders (vision).


Overall Study Flowchart

Recruitment

Oral presentation, leaflets, newspaper

Initial contact via phone

Informed consent and baseline assessments

Randomization (n = 160)

GermanyIntervention Group - n = 31

Control Group - n = 30

SpainIntervention Group - n = 22


AustraliaIntervention Group - n = 29


16 week iStoppFalls exercise intervention

Assessments post intervention

8-week follow-up with falls calendars


Methods & MeasurementsiStoppFalls - ICT based System to Predict & Prevent Falls

Measurements

Primary Outcomes: 1) Fall Risk (PPA Score, Lord et al. 2003) 2) Quality of Life (EQ-5D, www.euroqol.org)

Secondary Outcomes:Physical: TUG, SPPB, STS, Gait ST/DT, sensor-basedCognitive: MiniCog, ACE-III, TMT, ANT, DST, VSTHealth: WHODAS, Icon-FES, PHQ-9, PAQ, IPEQTechnology: SUS, PACES, TAM, DART, AFSS

Main outcome variables: repeated measure analysis of variance (ANOVA) or time (pre/post) and group (intervention/control).

Subgroups were tested by ANOVA and independent t-test


Intervention/ControliStoppFalls - ICT based System to Predict & Prevent Falls

Intervention/Control

Intervention Group: Exergame & SMM Exergame:1) Strength exercise: 3-times per week (60 min per week)2) Balance games: 3-times per week (120 min per week)3) Falls Risk Assessment: at least every 4 weeksExercises and games were due to a progression:Exercises: number of sets, repetitions and weights (1-3 kg)Games: level-difficulty and different dual tasks

SMM: Use the SMM during the whole day (indoors and outdoors).Re-charge it over night.

Control Group: Educational booklet only (falls & fall prevention).



Study Design

ParticipantCharacteristics


Participant Characteristics iStoppFalls - ICT based System to Predict & Prevent Falls

Intervention Group Control Group Overall P

Mean ± SD n (%)

Mean ± SD n (%)

Mean ± SD n (%)

ANOVA

Age (years) 74.71 ± 6.66 74.65 ± 6.03 74.68 ± 6.34 .960

Gender (n) 43 (55.8%) 50 (66.7%) 93 (61.2%) .185

Drugs (n) 3.52 ± 3.12 3.14 ± 2.49 3.34 ± 2.83 .413

EQ‐5D (index) 0.860 ± 0.120 0.860 ± 0.113 0.860 ± 0.128 .979

PPA (score) .615 ± .886 .546 ± .901 .581 ± .891 .635

Fall history (n) 25 (32.5%) 26 (35.6%) 51 (34%) .732



Results

Adherence


Drop-OutsiStoppFalls - ICT based System to Predict & Prevent Falls

Intervention Group Control Group Overall

N (%) N (%) N (%)

Full Drop‐Outs 10 (12,8%) 13 (17,3%) 23 (15%)

Drop‐Outs ITT 5 (6,4%) 0 (0%) 5 (3,3%)

Reasons for drop-outs:

Intervention group:technical (5), health (5), moving away (2), new furniture (1), family issues (1), other (1)

Control group: health (7), randomization (3), caring for partner (1), going away (1), other (1)


Total Exergame AdherenceiStoppFalls - ICT based System to Predict & Prevent Falls

Exercises Games Assessments TOTAL

Sessions per person/week (#) 14 6 1 21Duration per person/week (minutes) 30 19 2 51

Exercises Games Assessments TOTAL

Sessions per person/week (#) 14 6 1 21Duration per person/week (minutes) 20 14 2 36

Raw Data

Cleaned Data

Including instructions

Excluding instructions


SMM Measures per PersoniStoppFalls - ICT based System to Predict & Prevent Falls

Distance per person(km)

Wearing time per person (hours)

Distance per time (meter/hour)

SMM Measures (n=70, mean ± SD) 82 ± 62 522 ± 136 140 ± 96


iStoppFalls RCTiStoppFalls - ICT based System to Predict & Prevent Falls

Primary Outcomes


Fall Risk – PPA (total score)iStoppFalls - ICT based System to Predict & Prevent Falls

p < 0.05 (time*group)ANOVA


Quality of Life EQ-5D (index)iStoppFalls - ICT based System to Predict & Prevent Falls

p = N.S. (time*group)ANOVA


Overview, iStoppFalls RCT iStoppFalls - ICT based System to Predict & Prevent Falls

Exercise duration per week

Subgroup Analysis


Subgroup Analysis: CharacteristicsiStoppFalls - ICT based System to Predict & Prevent Falls

High‐adherence group >90 min.

(n = 18)

Low‐adherence group <90 min.

(n = 53)

P(T‐Test)

Age 73.11 ± 6.70 74.93 ± 6.30 .303

Gender 12 (66.7%) 26 (49.1%) .275

BMI 24.75 ± 3.47 26.54 ± 4.01 .333

Education 11.56 ± 4.81 11.31 ± 4.93 .564

PAQ hours 37.24 ± 17.93 41.92 ± 25.98 .606

IPEQ hours 32.08 ± 11.52 28.64 ± 18.22 .620


Subgroup Analysis: PPA-Total ScoreiStoppFalls - ICT based System to Predict & Prevent Falls

0,000

0,200

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1,200

Pre Post Pre Post

High-adherence Group (n=18) low-adherence Group (n=53)

PPA Total Score [mean±SE] p < 0.05 (time*group)ANOVA


Subgroup Analysis: PPA-SwayiStoppFalls - ICT based System to Predict & Prevent Falls

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200,000

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1400,000

Pre Post Pre Post


PPA Sway ap*ml (mm2) [mean±SE] p < 0.05 (time*group)ANOVA


Subgroup Analysis: EQ-5D VASiStoppFalls - ICT based System to Predict & Prevent Falls

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Pre Post Pre Post


EQ-5D VAS [mean±SE] p = 0.052 (time*group)ANOVA


Overview, iStoppFalls RCT iStoppFalls - ICT based System to Predict & Prevent Falls

Baseline Fall Risk

Subgroup Analysis


Subgroup Analysis: CharacteristicsiStoppFalls - ICT based System to Predict & Prevent Falls

Low‐PPA Score group < 0.540

(n = 38)

High‐PPA Score group > 0.540

(n = 39)

Control Group(n=75)

P(ANOVA)

Age 73.6 75.5 74.7 .406

Gender 17 (44.7%) 26 (66.7%) 50 (66.7%) .056

BMI 25.6 26.6 26.5 .414

Education 11.5 11.5 11.1 .835


Subgroup Analysis: PPA-Total ScoreiStoppFalls - ICT based System to Predict & Prevent Falls

p < 0.001 (time*group)ANOVA



Summary & Conclusions


iStoppFalls RCT Summary (1)iStoppFalls - ICT based System to Predict & Prevent Falls

Summary

The use of the iStoppFalls system was safe and feasible(usability, accessibility, user experience and acceptance).

Overall adherence to the intervention was good, but did not reach the scheduled dose of exercise (180 min per week) for the exergame alone.

But together with the measures of the daily outdoor activities(SMM), most participants of the intervention group didreach the respective dosage of exercise.


iStoppFalls RCT Summary (2)iStoppFalls - ICT based System to Predict & Prevent Falls

Summary

Primary objective 1) „Reduction of Fall Risk“ could be demonstrated for the whole group (p<0.05).

Primary objective 2) “Improvement of Quality of Life”could not be demonstrated for the whole group.

Subgroup analyses showed promising results:- Exercise Duration (More Training => Lower Fall Risk) - Baseline Fall Risk (High Baseline PPA => Lower Fall Risk)


iStoppFallsiStoppFalls - ICT based System to Predict & Prevent Falls

We thank all Study Participantswww.istoppfalls.eu


iStoppFallsiStoppFalls - ICT based System to Predict & Prevent Falls

Thank You

www.istoppfalls.eu

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