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A Validation Study of the Novel Application of Telehealth in Clinical Drug Development in Subjects With Mild Cognitive Deficits (REINVENT)

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ClinicalTrials.gov Identifier: NCT02778438
Recruitment Status : Completed
First Posted : May 19, 2016
Last Update Posted : September 27, 2016
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Quintiles, Inc.

Brief Summary:
REINVENT is a non-interventional, multi-center, research network-based cross-over study evaluating the potential utility of a telehealth platform in improving the efficiency of clinical trials. The study aims to enroll 30 subjects from primary care practices coordinated through a single main study site. Potential subjects will be screened and randomized (1:1) at Visit 1 into a 2-period crossover design study where 4 standard cognitive outcome measures are administered at Visits 2 (Day 30 ±7) and 3 (Day 90 ±7), either remotely or during an in-person visit.

Condition or disease
Mild Cognitive Impairment Alzheimer's Disease

Detailed Description:

Mobile platforms have been leveraged in a variety of industries to drive dramatic efficiency gains. The technology enables redesign of key processes allowing for the more efficient use of labor and capital leading to better performance outcomes. Telehealth is the use of electronic information and mobile telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health and health administration. Much of the focus for the Institute of Medicine and other government agencies has been the application of telehealth to improve access to healthcare and specialized expertise by extending the reach of scarce resources to underserved populations. These platforms are also routinely deployed as disease management tools. A natural extension of these aims is the use of telehealth in the clinical development process, where both improved efficiency and the ability to be more inclusive of a broader patient population are critical steps in modernizing the clinical trial.

REINVENT is a non-interventional, multi-center, research network-based cross-over study evaluating the potential utility of a telehealth platform in improving the efficiency of clinical trials. The study aims to enroll 30 subjects from between 9 and 11 qualified Radiant Clinical Research primary care physicians (PCP), coordinated through a single main study site. Potential subjects will be screened and randomized (1:1) at Visit 1 into a 2-period crossover design study where 4 standard cognitive outcome measures are administered at Visits 2 (Day 30 ±7) and 3 (Day 90 ±7), either remotely or during an in-person visit. A 60-day interval is required between Visits 2 and 3 to reduce learning effects commonly observed with repeated administration of cognitive assessments.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: REINVENT:A Validation Study of the Novel Application of Telehealth in Clinical Drug Development in Subjects With Mild Cognitive Deficits
Study Start Date : February 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Telehealth




Primary Outcome Measures :
  1. Change in Mini Mental State Examination [ Time Frame: 30 days, 90 days ]
  2. Change in Clinical Dementia Rating Sum of Boxes [ Time Frame: 30 days, 90 days ]
  3. Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale [ Time Frame: 30 days, 90 days ]
  4. Change in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ Time Frame: 30 days, 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
30 subjects with mild cognitive impairment due to AD, based on core clinical diagnostic criteria from the National Institute on Aging and Alzheimer's Association workgroup [Albert 2011]
Criteria

Inclusion Criteria:

  • Age at screening 50 to 85 years, inclusive, at the time of informed consent.
  • Diagnosis of mild cognitive deficits due to AD based on the core clinical diagnostic criteria of the National Institute of Aging and Alzheimer's Association (Albert 2011; McKhann 2011) and reviewed centrally by a main study site Principal Investigator
  • Mini Mental State Examination (MMSE) score of 24-27, inclusive at screening
  • Subject (or legally authorized representative) is willing and able to provide written informed consent
  • Existence of a reliable study partner (i.e., someone who spends at least 2 days a week with the subject) or caregiver who is willing to attend study visits with the subject
  • Willing and able to travel to the main study site (via provided transportation) for either Visit 2 or Visit 3

Exclusion Criteria:

  • Any medical or neurological condition (other than AD) that might be a contributing cause of the subject's cognitive impairment
  • Have had a stroke or transient ischemic attack (TIA) or unexplained loss of consciousness in the past 1 year
  • Clinically significant psychiatric illness in past 6 months
  • Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
  • Alcohol or substance abuse in past 1 year
  • History of unstable angina, myocardial infarction, chronic heart failure (New York Heart Association Class III or IV), or clinically significant conduction abnormalities (e.g., unstable atrial fibrillation) within 1 year prior to Screening.
  • Uncontrolled hypertension defined as a systolic blood pressure [SBP]/diastolic blood pressure [DBP] readings > 165/100 mmHg at Screening, or persistent SBP/DBP readings prior to enrollment that in the opinion of the Investigator are indicative of chronic uncontrolled hypertension.
  • Any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, or impair the subject's ability to perform cognitive testing.
  • Use of allowed chronic medications at doses that have not been stable for at least 4 weeks prior to Screening Visit 1 or use of AD medications (including but not limited to donepezil, rivastigmine, galantamine, tacrine, and memantine) at doses that have not been stable for at least 8 weeks prior to Screening Visit 1.
  • Participation in any interventional clinical research study within 30 days prior to screening, or during study conduct
  • In the opinion of the Investigator, presence of any other clinical conditions (e.g., life expectancy, co-existing disease) or other characteristics that would likely interfere with completion of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778438


Locations
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United States, Arizona
Clinical Research Advantage, Inc / Neurological Physicians of Arizona, Inc
Gilbert, Arizona, United States, 85234
Sponsors and Collaborators
Quintiles, Inc.
Biogen
Investigators
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Principal Investigator: Jeffrey Shy, MD Clinical Research Advantage, Inc / Neurological Physicians of Arizona, Inc
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Responsible Party: Quintiles, Inc.
ClinicalTrials.gov Identifier: NCT02778438    
Other Study ID Numbers: REI-001
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders