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| Name | Class |
|---|---|
| Hospital Universitario de Burgos | OTHER |
| Instituto de Salud Carlos III | OTHER_GOV |
| University of Burgos | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Active Comparator | The study group will receive the multidisciplinary tele-health intervention plus standard medical care |
|
| Control group | Placebo Comparator | The control group will receive the best standard medical care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist) | Procedure | Non-pharmacological and pharmacological treatment provided by telemedicine plus in-office visits |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of falls reduction | Comparison of incidence of falls between the study and control groups by using diaries and wearable sensors | 8 months |
| Feasibility | Number of virtual videoconferences completed | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness | To compare the medical and non-medical direct costs between the study and control groups by using structured questionnaires | 8 months |
| Healt-related quality of life | To compare the PDQ-39 scores between the study and control groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Burgos | Burgos | 09006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34932580 | Derived | Cubo E, Garcia-Bustillo A, Arnaiz-Gonzalez A, Ramirez-Sanz JM, Garrido-Labrador JL, Valinas F, Allende M, Gonzalez-Bernal JJ, Gonzalez-Santos J, Diez-Pastor JF, Jahouh M, Arribas J, Trejo J. Adopting a multidisciplinary telemedicine intervention for fall prevention in Parkinson's disease. Protocol for a longitudinal, randomized clinical trial. PLoS One. 2021 Dec 21;16(12):e0260889. doi: 10.1371/journal.pone.0260889. eCollection 2021. |
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MAIN RESULTS
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D000072141 | Neurologists |
| D009726 | Nurses |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D010820 | Physicians |
| D006282 | Health Personnel |
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Single blind, randomized, case-control study
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The rater will be blind to the patient status (study vs. control).
|
| Standard in-office medical care | Other | Non-pharmacological and pharmacological treatment provided in-office visits |
|
| 8 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D005159 |
| Health Care Facilities Workforce and Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |