Trial record 5 of 7 for:    LCIG

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01956032
First received: September 30, 2013
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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.


Condition
Parkinson's Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Levodopa Carbidopa Intestinal Gel Home Titration Using Telemedicine: Evaluation of Use of Resources

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 10
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)
Groups/Cohorts
Parkinson's disease
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients admitted to motor disorder speciality clinics.

Criteria

Inclusion Criteria:

  • Suitable for Levodopa Carbidopa Intestinal Gel treatment in accordance with the Swedish Summary of Product Characteristics
  • >18 years of age
  • Motivated and confident to test Levodopa Carbidopa Intestinal Gel home titration by using Telemedicine
  • Able to handle the infusion pump and the Telemedicine equipment by themselves or with assistance, as determined by the Investigator.
  • Able to understand and sign the study informed consent form

Exclusion Criteria:

  • Dementia or cognitive decline with Mini Mental State Examination score < 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, Other contraindications for abdominal surgery.
  • Any other reasons making the patient unsuitable for home titration using Telemedicine, as determined by the Investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01956032

Contacts
Contact: Anna Urbom, BS +46 70 16 80 818 anna.urbom@abbvie.com
Contact: Ewa Berndtson +46 70 337 43 73 ewa.berndtson@abbvie.com

Locations
Sweden
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         
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Eva Dahl, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01956032     History of Changes
Other Study ID Numbers: P14-000
Study First Received: September 30, 2013
Last Updated: May 2, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by AbbVie:
LCIG
Parkinson's disease
levodopa carbidopa intestinal gel
Telemedicine

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa
Levodopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Dopamine Agonists
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on July 28, 2014