Duodopa Home Titration Using Telemedicine: Evaluation of Use of Resources

NCT ID: NCT01956032

Last Updated: 2016-02-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-11-30

Brief Summary

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

Detailed Description

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.

Conditions

Parkinson's Disease

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with Parkinson's disease

Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.

Other name for Duodopa is Levodopa Carbidopa Intestinal Gel (LCIG).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Suitable for Duodopa treatment in accordance with the Swedish Summary of Product Characteristics

2. Motivated and confident to test Duodopa home titration using TM

3. Participants who were able to handle the infusion pump and the TM equipment by themselves or with assistance, as determined by the Investigator

4. Understood and signed the study informed consent form

Exclusion Criteria

1. Dementia or cognitive decline with Mini Mental State Examination score less than 24

2. Ongoing symptomatic depression, hallucinations or other psychotic behaviors without adequate treatment, as determined by the Investigator

3. 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

4. Other reasons that made the participant unsuitable for home titration using TM, as determined by the Investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Dahl, MD

Role: STUDY_DIRECTOR

AbbVie

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

P14-000

Identifier Type: -

Identifier Source: org_study_id