Duodopa Home Titration Using Telemedicine: Evaluation of Use of Resources

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.

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.

The total time for titration period was defined as the number of minutes from the start of the pump after application of the naso-jejunal tube (Day 1) until Investigator's decision to terminate Duodopa treatment. Data are presented as time in minutes per participant with a minimum and maximum range.

Participant's daily free time was a maximum 24 hours, and was defined as the time spent on activities (e.g. work, household, chores, leisure time, travel, sleep, etc.) other than time spent on health care professional (the DNS and the Investigator) communication, dose adjustments and pump handling. Time for dose adjustments, health care professional communication via TM and pump handling were subtracted from the amount of participant's daily free time. The participant was asked to note the time used for independent dose adjustments and pump handling in a participant diary. Participant's total free time was calculated as the sum of participant's daily free time for all days during the titration period. Data are presented as time in minutes per participant with a minimum and maximum range.

Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the number of participants in the FAS population.

Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the total number of technical events (34).

Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the number of participants in the FAS population.

Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the total number of consequences (43).

Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the number of participants in the FAS population.

Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the total number of technical events (34).

The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 1 (How satisfied were you with using TM when starting Duodopa?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 2 (Did you do things when at home that you could not have done if you were hospitalized during the titration?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 3 (How easy was the TM equipment to use?) where 1 was 'very hard' and 7 was 'very easy'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 4 (How satisfied were you with the video conversation with your Investigator?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 5 (How satisfied were you with the video conversation with your DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 6 (How satisfied were you with the 3-part video conversations with Investigator and DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 7 (How satisfied were you with the amount of time the DNS were at your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 8 (How satisfied were you with having the technical equipment in your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 9 (How satisfied were you with the technician's visits to set up and dismantle the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 10 (How confident do you feel regarding the pump and the dose adjustments?) where 1 was ' very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 11 (How secure did you feel being at home and communicating by TM, when titrating Duodopa?) where 1 was 'very unsecure' and 7 was 'very secure'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 12 (Knowing what you know now, would you rather have stayed in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 13 (how satisfied were you with the titration at the participant's home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 14 (Where you able to perform daily activities during the titration period?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 15 (How confident did you feel about helping with the pump?) where 1 was ' Very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

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. The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 16 (knowing what you know now, would you rather have had your spouse in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 1 (How satisfied were you with the TM concept comports with your clinical needs?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 2 (How satisfied were you with using TM for communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 3 (How satisfied were you with using TM for clinical assessments?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 4 (How satisfied were you with the image quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 5 (How satisfied were you with the sound quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 6 (How satisfied were you with the user interphase for the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 7 (How satisfied were you with the setup and maintenance of the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 8 (How satisfied were you regarding participant safety using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 9 (How satisfied were you with the participant contact when using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'yes' or 'no' for 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?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for 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?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for 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?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for 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?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 14 (How satisfied were you with replacing the participant home visit with TM communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

CGI-I was used to document the Investigator's impression of the participant's improvement in Parkinson's Disease symptoms throughout the study. The CGI-I was measured on a 7-point scale: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse, where 1 through 3 indicated positive answers. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.

The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of health care provider (general practitioner, emergency ward, other neurologist, and other).

The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of contact (other, telephone, home or outpatient visit, and hospitalization).

The time spent in minutes for health care utilization outside the TM care chain was assessed. Data are presented as time in minutes with a minimum and maximum range.