N/A
Completed N=15
Duodopa Home Titration Using Telemedicine: Evaluation of Use of Resources
Source: ClinicalTrials.gov NCT01956032 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant — 29.1; 22.2; 30.0; NA Minutes
Summary
The purpose of this study was to evaluate the use of resources during titration of Duodopa at home.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant |
29.1; 22.2; 30.0; NA; NA; 317.4 | — |
| PRIMARY Median Number of Contacts |
19.0; 13.0; 1.0; 5.0; 0.0; 3.0 | — |
| SECONDARY Median Total Time for Titration |
4093.2 | — |
| SECONDARY Median Total Free Time of Participant |
3865.2 | — |
| SECONDARY Percentage of Participants Who Experienced Technical Events |
73.3; 13.3; 6.7; 0.0; 0.0; 13.3 | — |
| SECONDARY Incidence of Technical Events Experienced by Participants |
100.0; 5.9; 2.9; NA; NA; 8.8 | — |
| SECONDARY Percentage of Participants With Consequences |
73.3; 6.7; 0.0; 20.0; 20.0; 6.7 | — |
| SECONDARY Incidence of Consequences Due to Technical Events |
100.0; 2.3; NA; 7.0; 11.6; 2.3 | — |
| SECONDARY Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence |
73.3; 6.7; 6.7; 20.0; 0.0; 0.0 | — |
| SECONDARY Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence |
100.0; 2.9; 2.9; 8.8; NA; NA | — |
| SECONDARY Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa? |
0.0; 0.0; 0.0; 7.1; 7.1; 28.6 | — |
| SECONDARY 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? |
92.9 | — |
| SECONDARY Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use? |
0.0; 0.0; 0.0; 7.1; 7.1; 35.7 | — |
| SECONDARY Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator? |
0.0; 0.0; 0.0; 0.0; 14.3; 28.6 | — |
| SECONDARY Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS? |
0.0; 0.0; 0.0; 0.0; 7.1; 35.7 | — |
| SECONDARY 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)? |
0.0; 0.0; 0.0; 0.0; 7.1; 21.4 | — |
| SECONDARY 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? |
0.0; 0.0; 0.0; 0.0; 7.1; 28.6 | — |
| SECONDARY 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? |
0.0; 0.0; 7.1; 0.0; 14.3; 0.0 | — |
| SECONDARY 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? |
0.0; 0.0; 7.1; 0.0; 7.1; 21.4 | — |
| SECONDARY 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? |
0.0; 0.0; 0.0; 0.0; 14.3; 42.9 | — |
| SECONDARY 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? |
0.0; 0.0; 0.0; 7.1; 14.3; 14.3 | — |
| SECONDARY 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? |
92.9 | — |
| SECONDARY 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? |
0.0; 0.0; 0.0; 0.0; 0.0; 11.1 | — |
| SECONDARY 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? |
88.9 | — |
| SECONDARY 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? |
0.0; 0.0; 0.0; 0.0; 16.7; 16.7 | — |
| SECONDARY 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? |
100.0 | — |
| SECONDARY 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? |
0.0; 0.0; 0.0; 6.7; 0.0; 53.3 | — |
| SECONDARY Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication? |
0.0; 0.0; 0.0; 0.0; 13.3; 46.7 | — |
| SECONDARY 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? |
0.0; 0.0; 6.7; 0.0; 6.7; 46.7 | — |
| SECONDARY 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? |
0.0; 0.0; 6.7; 0.0; 0.0; 26.7 | — |
| SECONDARY 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? |
0.0; 0.0; 6.7; 6.7; 26.7; 46.7 | — |
| SECONDARY 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? |
0.0; 0.0; 0.0; 0.0; 13.3; 13.3 | — |
| SECONDARY 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? |
0.0; 0.0; 0.0; 0.0; 20.0; 60.0 | — |
| SECONDARY Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM? |
0.0; 0.0; 0.0; 0.0; 13.3; 46.7 | — |
| SECONDARY 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? |
0.0; 0.0; 0.0; 0.0; 6.7; 26.7 | — |
| SECONDARY 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? |
73.3; 60.0 | — |
| SECONDARY 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? |
0.0; 40.0; 60.0; 0.0; 6.7; 93.3 | — |
| SECONDARY 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? |
6.7; 26.7; 66.7; 26.7; 13.3; 60.0 | — |
| SECONDARY 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? |
53.3; 40.0; 6.7; 93.3; 6.7; 0.0 | — |
| SECONDARY 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? |
0.0; 0.0; 0.0; 6.7; 13.3; 20.0 | — |
| SECONDARY Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms |
28.6; 71.4; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider |
0; 0; 0; 1 | — |
| SECONDARY Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact |
0; 0; 1; 0 | — |
| SECONDARY Median Time Spent for Health Care Utilization Outside the TM Care Chain |
190.8 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01956032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.