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Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to see how feasible and how satisfied participants/caregivers/investigators are with video-assisted telenursing use in nurse support programs with LCIG.
LCIG is an approved drug to treat PD. Approximately 50 adult participants with advanced PD will be enrolled in the study at approximately 10 sites across the world.
The study has 2 groups. In one group, around 25 participants will receive nurse support using video devices. In the second group, around 25 participants will receive nurse support without using video devices. All participants will attend a baseline visit and follow up visits at Week 4 and Week 12. The planned observation period will be 12 weeks.
Participants who are prescribed LCIG by their physicians will have three study related visits. Participants, caregivers, and investigators will be asked to complete questionnaires for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants With Nurse Support, Using Video Devices | Participants treated with Levodopa Carbidopa Intestinal Gel (LCIG) in accordance with approved label who are provided AbbVie Duodopa Specialist (ADS) nurse support, using video devices. | ||
| Participants With Nurse Support, Not Using Video Devices | Participants treated with Levodopa Carbidopa Intestinal Gel (LCIG) in accordance with approved label who are provided AbbVie Duodopa Specialist (ADS) nurse support, not using video devices. |
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| Measure | Description | Time Frame |
|---|---|---|
| Participant Acceptance of the AbbVie Duodopa Specialist (ADS) Nurse Support and Communication Access | Participant acceptance is measured by the participant satisfaction with the AbbVie Duodopa Specialist (ADS) nurse support and communication access (Visual Analog Sore from 1 to 10). | At Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction With ADS Nurse Support and Communication Access | Participant Satisfaction is defined as participant satisfaction with the ADS nurse support and communication access at Week 4 (Visual Analog Scale [VAS] scoring from 1 to 10) and at Week 12 (VAS scoring from 8 to 10). | Through Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with advanced Parkinson's Disease
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brisbane and Women's Hospital /ID# 223138 | Herston | Queensland | 4029 | Australia | ||
| Kingston Centre /ID# 222563 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39224799 | Derived | Gurevich T, Evans A, Hassin-Baer S, Kagi G, Koziorowski D, Roszmann A, Bergmann L, Parra Riaza JC, Sanchez-Solino O, Slawek J. Satisfaction with videoconferencing support for levodopa-carbidopa intestinal gel: An observational study. Digit Health. 2024 Aug 30;10:20552076241271847. doi: 10.1177/20552076241271847. eCollection 2024 Jan-Dec. |
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| Participant Satisfaction with the ADS Nurse Support and Communication Access |
Participant satisfaction with the ADS nurse support and communication access is based on scoring 8 to 10 on a VAS (Binary: Yes/No). |
| At Week 12 |
| Caregiver Satisfaction With ADS Nurse Support and Communication Access | Caregiver satisfaction is measured as the satisfaction of caregiver with the ADS nurse support and communication access at weeks 4 and 12 (VAS from 1 to 10). | Baseline (Week 0) to Week 12 |
| Caregiver Acceptance of ADS Nurse Support and Communication Access | Caregiver acceptance is measured as the acceptance of caregiver with the ADS nurse support and communication access at weeks 4 and 12 (VAS from 1 to 10). | Through Week 12 |
| Investigator Satisfaction With Nurse Support | Investigator satisfaction is measured as the satisfaction of investigator with the nurse support (VAS from 1 to 10). | At Week 12 |
| Participant Satisfaction With Video Functionality of the Device | Participant satisfaction is defined as the measure of satisfaction of participant with the video functionality of the device specifically at weeks 4 and 12 (VAS from 1 to 10). | Through Week 12 |
| Change of Caregiver Burden | Change of caregiver burden will be measured by the Modified Caregiver Strain Index (MCSI). MCSI is a questionnaire comprising of 13 questions around major domains, to be filled by caregivers. The higher the score, the higher the level of caregiver strain. Scoring ranges from 0 to 26, with 0 indicating no strain and 26 indicating extreme strain. | Baseline (Week 0) to Week 12 |
| Cheltenham |
| Victoria |
| 3192 |
| Australia |
| The Royal Melbourne Hospital /ID# 223005 | Parkville | Victoria | 3050 | Australia |
| Soroka University Medical Center /ID# 222754 | Beersheba | Southern District | 8410101 | Israel |
| The Chaim Sheba Medical Center /ID# 222470 | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Kaplan Medical Center /ID# 222753 | Rehovot | 7661041 | Israel |
| Tel Aviv Medical Center /ID# 222471 | Tel Aviv | 64239 | Israel |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 222934 | Wroclaw | Lower Silesian Voivodeship | 50-369 | Poland |
| Mazowiecki Szpital Brodnowski /ID# 222933 | Warsaw | Masovian Voivodeship | 03-242 | Poland |
| COPERNICUS Podmiot Leczniczy Sp. z o.o. - Szpital sw. Wojciecha Adalberta /ID# 222932 | Gdansk | Pomeranian Voivodeship | 80-462 | Poland |
| Luzerner Kantonsspital /ID# 223038 | Lucerne | Canton of Lucerne | 6000 | Switzerland |
| Kantonsspital St. Gallen /ID# 227012 | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| Universitätsspital Zürich /ID# 223035 | Zurich | Canton of Zurich | 8091 | Switzerland |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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