Age and ageing Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient has provided written informed consent for participation in the study 2. Age 60 years and over 3. Clinically significant fear of falling as defined by a Falls Efficacy ScaleInternational Version score of greater than 23 4. Male and female participants
Exclusion criteria
Exclusion criteria: 1.Patients with cognitive impairment (mini-mental state examination MMSE less than 24) 2. Life expectancy less than 1 year or unlikely for any other reason to be unable to complete one year follow-up duration 3. Patients requiring psychosocial interventions unrelated to fear of falling 4. Current involvement in other investigational studies or trials, or involvement within 30 days prior to study entry 5. Patients who have taken part in part 1 of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fear of falling as measured by the Falls Efficacy Scale International (FES-I) measured at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cost Effectiveness measured at 6 months and 12 months post randomisation 2. EUROHIS-QOL-8 and WHO QOL OLD measured at 8 weeks, 6 months and 12 months post randomisation 3. EuroQoL-5 Dimensions Scale measured at 8 weeks, 6 months and 12 months post randomisation 4. Falls measured throughout follow-up 5. Functional Reach measured at 8 weeks, 6 months and 12 months post randomisation 6. Hospital Anxiety & Depression Score (HADS) measured at 8 weeks, 6 months and 12 months post randomisation 7. Isometric Hand Grip Strength measured at 8 weeks, 6 months and 12 months post randomisation; Lubben Social Network Scale 6; Timepoint(s): 8 weeks, 6 months and 12 months post randomisation 8. Numeric rating scale for fear of falling when walking measured at 8 weeks, 6 months and 12 months post randomisation 9. Patient Generated Index (PGI) measured at 8 weeks, 6 months and 12 months post randomisation 10. Short Form 36 (SF-36) measured at 8 weeks, 6 months and 12 months post randomisation 11. Short Physical Performance Battery measured at 8 weeks, 6 months and 12 months post randomisation 12. Social Participation Questionnaire measured at 8 weeks, 6 months and 12 months post randomisation 13. The De Jong-Gierveld Loneliness Scale measured at 8 weeks, 6 months and 12 months post randomisation | — |
Countries
United Kingdom