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临床试验/NCT01956032
NCT01956032已完成不适用

Levodopa Carbidopa Intestinal Gel Home Titration Using Telemedicine: Evaluation of Use of Resources

AbbVie0 个研究点目标入组 15 人开始时间: 2013年9月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
主要终点
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study was to evaluate the use of resources during titration of Duodopa at home.

详细描述

Telemedicine (TM) offers an alternative titration procedure allowing the start of Duodopa infusion at home. The study evaluated the use of resources, measured as the number of contacts and time spent by health care professionals (Duodopa nurse specialists and the study Investigators) and the TM technician, during Duodopa infusion at home. Data was collected from four (4) clinical centers in Sweden. Data collection period for each participant started at the decision to administer Duodopa treatment (Baseline) and ended when the Duodopa titration period was complete. Post-titration, the participants and caregiver were interviewed and the investigators and nurses answered a web based questionnaire on their experiences.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Suitable for Duodopa treatment in accordance with the Swedish Summary of Product Characteristics
  • •Motivated and confident to test Duodopa home titration using TM
  • •Participants who were able to handle the infusion pump and the TM equipment by themselves or with assistance, as determined by the Investigator
  • •Understood and signed the study informed consent form

排除标准

  • •Dementia or cognitive decline with Mini Mental State Examination score less than 24
  • •Ongoing symptomatic depression, hallucinations or other psychotic behaviors without adequate treatment, as determined by the Investigator
  • •Contraindications as described in the Swedish Summary of Product Characteristics: hypersensitivity to levodopa or carbidopa, narrow angle glaucoma, serious liver and kidney disease, severe heart failure, acute myocardial infarction, severe cardiac arrhythmias, recent or acute stroke, contraindications for adrenergic effects; pheochromocytoma, hyperthyroidism, cushing's syndrome, and other contraindications for abdominal surgery
  • •Other reasons that made the participant unsuitable for home titration using TM, as determined by the Investigator

结局指标

主要结局

Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant

时间窗: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days

Health care professional time was defined as the number of minutes the individual had contact with the participant visiting their home, assisting with TM equipment, or by telephone. TM technician time was defined as the number of minutes spent for setup, demounting, and adjustments to the TM equipment. Data are presented as the time in minutes for communication between the following individuals and summarized by the type of contact (all types, TM, telephone, home visit, and other): (1) Participant + Investigator time; (2) Participant + DNS time; (3) Participant + Investigator + DNS time; (4) Participant + TM technician time; (5) Total Investigator time; (6) Total DNS time; and (7) Total participant time.

Median Number of Contacts

时间窗: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days

Contacts (total, TM, telephone, home visit, and other) during the study period between the participant, the health care professional (the DNS and the Investigator) and TM technician were counted and summarized by type. Data are presented as number of contacts per participant with a minimum and maximum range.

次要结局

  • Median Total Time for Titration(From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Percentage of Participants Who Experienced Technical Events(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Knowing What You Know Now, Would You Rather Have Stayed in the Hospital to Start Duodopa Treatment?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Incidence of Technical Events Experienced by Participants(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Percentage of Participants With Consequences(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: Did You do Things When at Home That You Could Not Have Done if You Were Hospitalized During the Titration?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Median Total Free Time of Participant(From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Incidence of Consequences Due to Technical Events(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 16 for Caregiver: Knowing What You Know Now, Would You Rather Have Had Your Spouse in the Hospital to Start Duodopa Treatment?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 14 for Caregiver: Where You Able to Perform Daily Activities During the Titration Period?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Positive (Investigator and DNS) Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: Did You Lack Any Dimensions in the Assessment of the Participant Using TM That You Have in the Classical Titration at Hospital?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts?(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)
  • Median Time Spent for Health Care Utilization Outside the TM Care Chain(From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days)

研究者

发起方
AbbVie
申办方类型
Industry
责任方
Sponsor

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