Parkinson Disease
Conditions
Keywords
Falls, Cost-effectiveness, Qaly
Brief summary
Falls in Parkinson's Disease (PD) are very frequent with often devastating consequences, increasing comorbidity, mortality, decreased quality of life and increased socio-health costs. In this national, single-center, single-blind, randomized, case-control study, non-demented patients with idiopathic PD with high risk of falling will be included. The main objective of this study is to determine the cost-effectiveness of a home-based, multidisciplinary tele-health intervention to decrease the risk of falling.
Detailed description
In this study, PD patients using multidisciplinary tele-health intervention (study group) will be compared to age, gender-matched PD patients receiving the best standard in-office clinical management (control group). Both groups will be followed for 8 months. The main outcome will be the comparison of incidence of falls between the study and control groups. Secondary outcomes will include the analysis of cost-effectiveness of multidisciplinary tele-health interventions. The results of this study will allow us to study the feasibility of remote health care to prevent falls in patients with PD, allowing equity in the distribution and access to specialized health care.
Interventions
OTHERStandard in-office medical care
Non-pharmacological and pharmacological treatment provided in-office visits
PROCEDUREMultidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist)
Non-pharmacological and pharmacological treatment provided by telemedicine plus in-office visits
Sponsors
Hospital Universitario de Burgos
Instituto de Salud Carlos III
University of Burgos
Esther Cubo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The rater will be blind to the patient status (study vs. control).
Intervention model description
Single blind, randomized, case-control study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Non-demented patients * Patients diagnosed with idiopathic Parkinson´s disease * Patients able to walk with a Hoehn Yahr stage \< 3
Exclusion criteria
* Non-ambulatory patients with Parkinson´s disease * Patients diagnosed with significant comorbidity (psychiatric, systemic, hearing or visual disturbances) according to the investigator criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of falls reduction | 8 months | Comparison of incidence of falls between the study and control groups by using diaries and wearable sensors |
| Feasibility | 8 months | Number of virtual videoconferences completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness | 8 months | To compare the medical and non-medical direct costs between the study and control groups by using structured questionnaires |
| Healt-related quality of life | 8 months | To compare the PDQ-39 scores between the study and control groups |
Countries
Spain
Outcome results
None listed