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Bariatric Surgery Telemedicine Study

This study has been withdrawn prior to enrollment.
(PI decided to not initiate this study.)
Sponsor:
Information provided by (Responsible Party):
Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT01378897
First received: June 21, 2011
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to evaluate a new educational program for people who have recently had gastric bypass surgery. This program involves both the use of newly developed wireless home monitoring technology (medication box, weight scale, and pedometer) and telephone-based, individually tailored health counseling with a bariatric dietician.


Condition Intervention Phase
Obesity
Device: MedSignals®pillbox,Omron pedometer,VitalSignals®weight scale
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Telehealth Innovation to Support Weight Loss

Resource links provided by NLM:


Further study details as provided by Baystate Medical Center:

Primary Outcome Measures:
  • usability questionnaire [ Time Frame: 2 month ] [ Designated as safety issue: No ]
    This pilot study involves the collection of descriptive data to assess feasibility, usability, and satisfaction with the devices. ). The method for collecting study data will be questionnaires (i.e., usability questionnaire, treatment satisfaction questionnaire, and feasibility questionnaire) and electronic data from the device downloads.


Estimated Enrollment: 30
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: MedSignals®pillbox,Omron pedometer,VitalSignals®weight scale
    Participants will use three home monitoring devices (i.e., weight scale, pedometer, pillbox) for two months. In addition, participants will receive weekly phone calls from the study's bariatric dietician during weeks 1-4 of the study and then receive biweekly calls during the second month. The structured phone calls (approximately 10-15 minutes each call) will focus on discussing the patient's adherence data, discussing any barriers to adherence, and providing tailored patient education.
Detailed Description:

Obesity, defined as a body mass index (BMI) >30 in kg/m2, has reached epidemic levels in the United States (US). Morbid obesity, which is classified as a BMI>=40, is the fastest growing obesity category. It has increased 52% between 2000 and 2005, to now affect 15 million US adults. Morbid obesity is associated with serious medical co-morbidities, and these obesity-related diseases have a significant impact on the individual patient, as well as on our healthcare system as a whole. Gastric bypass surgery is the only current effective treatment for MO. Approximately 220,000 operations were carried out in 2008, making it one of the most commonly performed procedures in the U.S. The most common form (80%) of bariatric surgery performed in the U.S. is laparoscopic gastric bypass (LGB). While there has been considerable clinical focus on multidisciplinary pre-surgical screening regarding medical, behavioral, and psychosocial suitability of candidates for bariatric surgery, there is a paucity of post-surgical follow-up examining behavioral adaptation and adherence. The purpose of this study is to examine such post-surgical behavioral components that are relevant to weight loss surgery. Specifically, the investigators will assess the feasibility, reliability, usability, and satisfaction of some newly developed wireless home monitoring technology (i.e., medication box, weight scale, and pedometer) in a group of patients who have recently had gastric bypass surgery. A prospective cohort study design will be conducted. Questionnaire data will be collected and data analysis will be descriptive in nature.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 weeks-1 year post gastric bypass surgery
  • > 18 years of age
  • English-speaking and able to read and understand consent form and study questionnaires.
  • Land line analog telephone service at home

Exclusion Criteria:

  • Suffered unexpected complications from surgery as judged by the surgeons
  • Anyone judged not fit to participate in the study, as per the surgeon or dietician's clinical judgment
  • Weight >440 lbs. at enrollment (upper limit of our weight scale)
  • Planning to relocate from the area within the next 2-3 months (i.e., during study timeframe)
  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: NCT01378897

Locations
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01105
Sponsors and Collaborators
Baystate Medical Center
Investigators
Principal Investigator: Garry W Welch, PhD Baystate Medical Center
  More Information

No publications provided

Responsible Party: Baystate Medical Center
ClinicalTrials.gov Identifier: NCT01378897     History of Changes
Other Study ID Numbers: BH-11-059
Study First Received: June 21, 2011
Last Updated: October 6, 2011
Health Authority: United States: Federal Government

Keywords provided by Baystate Medical Center:
bariatric surgery
gastric bypass surgery

ClinicalTrials.gov processed this record on November 25, 2014