Levodopa Carbidopa Intestinal Gel Home Titration Using Telemedicine: Evaluation of Use of Resources
The purpose of this study is to evaluate the use of resources, measured as number of contacts and time spent by the Duodopa Nurse Specialist, the Investigator, and the telemedicine Technician, during titration of Levodopa Carbodopa Intestinal Gel at home using Telemedicine.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Levodopa Carbidopa Intestinal Gel Home Titration Using Telemedicine: Evaluation of Use of Resources|
- Resource use [ Time Frame: 1 month ] [ Designated as safety issue: No ]Resource use is composed of the health care professional and technician time in hours used during the study period. Health care professional-time is defined as Duodopa Nurse Specialist- and Investigator time, in contact with patient by visiting the patient's home, by telemedicine equipment or by telephone. Telemedicine technician time will include time for telemedicine equipment setup, demounting and adjustments if needed.
- Total time for titration [ Time Frame: 1 month ] [ Designated as safety issue: No ]Total time for titration period is defined as the time in hours from start of the pump and Levodopa Carbidopa Intestinal Gel delivery via the naso-jejunal tube, to the decision of a permanent Percutaneous Endoscopic Gastrojejunostomy surgery or termination of Levodopa Carbidopa Intestinal Gel treatment.
- Patient's daily free time [ Time Frame: 1 month ] [ Designated as safety issue: No ]Patents daily free time is a maximum 24 hours, and is defined as time spent on activities (e.g. work, household, chores, leisure time, travel, sleep etc.) other than time spent on health care professional-communication, dose adjustments and pump handling.
- Technical feasibility [ Time Frame: 1 month ] [ Designated as safety issue: No ]Telemedicine equipment mishandling, intentional misuse, technical problems
- Health care utilization [ Time Frame: 1 month ] [ Designated as safety issue: No ]Other health care contacts related to Parkinson's Disease not scheduled within the telemedicine care chain
- Clinical Global Impression - Improvement [ Time Frame: 1 month ] [ Designated as safety issue: No ]Clinical Global Impression - Improvement will be used to document the Investigator's impression of the patients improvement from decision to start Levodopa Carbidopa Intestinal Geltitration (baseline) to decision on Percutaneous Endoscopic Gastrojejunostomy-surgery.
- Experience of Levodopa Carbidopa Intestinal Gelhome titration using Telemedicine [ Time Frame: 1 month ] [ Designated as safety issue: No ]Experience of Levodopa Carbidopa Intestinal Gel home titration using Telemedicine will be collected through semi-structured interviews with the patient and caregiver.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Patients diagnosed with Parkinson's disease with remaining disabling motor complications despite optimized per-oral or other treatment regimens suitable for Levodopa Carbidopa Intestinal Gel treatment in accordance with the Swedish Summary of Products Characteristics
Please refer to this study by its ClinicalTrials.gov identifier: NCT01956032
|Contact: Anna Urbom, BS||+46 70 16 80 firstname.lastname@example.org|
|Contact: Ewa Berndtson||+46 70 337 43 email@example.com|
|Site Reference ID/Investigator# 96718||Recruiting|
|Linkoping, Sweden, 581 85|
|Principal Investigator: Site Reference ID/Investigator# 96718|
|Site Reference ID/Investigator# 96720||Not yet recruiting|
|Lund, Sweden, 22185|
|Principal Investigator: Site Reference ID/Investigator# 96720|
|Site Reference ID/Investigator# 96721||Recruiting|
|Stockholm, Sweden, 141 86|
|Principal Investigator: Site Reference ID/Investigator# 96721|
|Site Reference ID/Investigator# 96719||Recruiting|
|Uppsala, Sweden, SE 75185|
|Principal Investigator: Site Reference ID/Investigator# 96719|
|Study Director:||Eva Dahl, MD||AbbVie|