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Trial record 63 of 68 for:    tpn

Teen and Young Adult Connections for Support From Multidisciplinary Professionals & Peers

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ClinicalTrials.gov Identifier: NCT02987569
Recruitment Status : Active, not recruiting
First Posted : December 9, 2016
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
12 month study testing mobile delivery of health information and connections to professionals and peers to improve health of teen/young adult HPN users.

Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Malabsorption Malnutrition Behavioral: mConnect plus mobile connections to multidisciplinary professionals & peers Behavioral: iPad use plus one mobile connections to multidisciplinary professionals & peers Device: iPad Not Applicable

Detailed Description:
This research study will test the effect of in-home/mobile HPN support delivered to teen and young adult home parenteral nutrition (HPN) patients and family members over handheld personal computers. Effects on health status, QoL, and fatigue will be assessed over time between groups of study subjects from the ages of 13 through 30 randomized to one of two groups. Group One (intervention group) will receive mConnect, integrated evidence-based interventions (skill-building games, restorative naps & peer support) via mobile iPad and Internet delivery plus two real-time audiovisual encrypted connections with multidisciplinary professionals and peers. Group Two (control group) will receive healthy activity information via mobile iPad and Internet delivery plus one real-time audiovisual encrypted connection with professionals and peers.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Teen Connections for Support From Multidisciplinary Professionals & Peers
Study Start Date : July 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group One
Intervention
Behavioral: mConnect plus mobile connections to multidisciplinary professionals & peers
mConnect is the integration of evidence-based HPN interventions delivered via professionally moderated iPad visual meetings with peers, and reinforced by HPN related skill-building games (apps) and iPad music guided short naps.

Device: iPad
Active Comparator: Group Two
Control
Behavioral: iPad use plus one mobile connections to multidisciplinary professionals & peers
iPad with a data plan and one professionally moderated iPad visual meeting with peers.

Device: iPad



Primary Outcome Measures :
  1. Health Survey SF-12v2 (predicts future health services use). [ Time Frame: T0 (baseline data collection) ]
    Physical and mental health status from each person's perspective. 7-Item Likert

  2. Quality of Life (Cantril Ladder) [ Time Frame: T0 (baseline data collection) ]
    Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert

  3. Beck Depression Inventory-II (BDI-II) [ Time Frame: T0 (baseline data collection) ]
    Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item

  4. Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities. [ Time Frame: T2 (month 1-2/mConnect intervention period) ]
    Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert

  5. Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities. [ Time Frame: T3 (month 3-4/mConnect intervention period) ]
    Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert

  6. Beck Depression Inventory-II (BDI-II) [ Time Frame: T3 (4 months: change from T0/baseline) ]
    Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item

  7. Health Survey SF-12v2 (predicts future health services use). [ Time Frame: T3 (4 months: change from T0/baseline) ]
    Physical and mental health status from each person's perspective. 7-Item Likert

  8. Quality of Life (Cantril Ladder) [ Time Frame: T3 (4 months: change from T0/baseline) ]
    Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert

  9. Health Survey SF-12v2 (predicts future health services use). [ Time Frame: T4 (8 months: change from T3/4 months) ]
    Physical and mental health status from each person's perspective. 7-Item Likert

  10. Quality of Life (Cantril Ladder) [ Time Frame: T4 (8 months: change from T3/4 months) ]
    Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert

  11. Beck Depression Inventory-II (BDI-II) [ Time Frame: T4 (8 months: change from T3/4 months) ]
    Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item

  12. Health Survey SF-12v2 (predicts future health services use). [ Time Frame: T5 (12 months: change from T4/8 months) ]
    Physical and mental health status from each person's perspective. 7-Item Likert

  13. Quality of Life (Cantril Ladder) [ Time Frame: T5 (12 months: change from T4/8 months) ]
    Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert

  14. Beck Depression Inventory-II (BDI-II) [ Time Frame: T5 (12 months: change from T4/8 months) ]
    Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item


Secondary Outcome Measures :
  1. Preparedness (measures skills needed for independent HPN home care). [ Time Frame: T0 (baseline data collection) ]
    Ability to manage home-care; low score = needs home care assistance. 8-Item Likert

  2. COOPS Social Support Scale [ Time Frame: T0 (baseline data collection) ]
    Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert

  3. Preparedness (measures skills needed for independent HPN home care). [ Time Frame: T3 (4 months: change from T0/baseline) ]
    Ability to manage home-care; low score = needs home care assistance. 8-Item Likert

  4. COOPS Social Support Scale [ Time Frame: T3 (4 months: change from T0/baseline) ]
    Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert

  5. Mobile Care Helpfulness & Willingness-to-Pay Fees for Distance Health. [ Time Frame: T4 (8 months) ]
    Rating of Helpfulness and willingness to pay for mobile care delivery. 10-Item Likert

  6. Preparedness (measures skills needed for independent HPN home care). [ Time Frame: T4 (8 months: change from T3/4 months) ]
    Ability to manage home-care; low score = needs home care assistance. 8-Item Likert

  7. COOPS Social Support Scale [ Time Frame: T4 (8 months: change from T3/4 months) ]
    Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert

  8. Preparedness (measures skills needed for independent HPN home care). [ Time Frame: T5 (12 months: change from T4/8 months) ]
    Ability to manage home-care; low score = needs home care assistance. 8-Item Likert

  9. COOPS Social Support Scale [ Time Frame: T5 (12 months: change from T4/8 months) ]
    Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Total parenteral nutrition (TPN) patients/users and family members/caregivers (defined as those individuals involved in daily home HPN care) age 13 and older
  • TPN users (also called HPN users) ages 13 through 30 must be receiving intravenous nutrition for a non-malignant short bowel disorder
  • Read, write, speak English and provide informed consent
  • Be able to participate in group clinic visits

Exclusion Criteria:

  • Enteral nutrition dependency only
  • Less than 13 years of age
  • 13 through 17 years of age without parental consent
  • Currently enrolled in an intervention study or HPN management program
  • Severe cognitive impairment
  • Disability disorders (e.g. blindness which cannot be accommodated for active participation in the group clinics

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): NCT02987569


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Carol E Smith, RN, PhD, FAAN University of Kansas Medical Center

Publications:
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02987569     History of Changes
Other Study ID Numbers: STUDY00004067
R01NR015743-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data is de-identified and will be reported only in aggregate.
Keywords provided by University of Kansas Medical Center:
Home Parenteral Nutrition
HPN
Total Parenteral Nutrition
TPN
mConnect
SBS
short bowel disorder
telehealth
telemedicine
Additional relevant MeSH terms:
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Short Bowel Syndrome
Malabsorption Syndromes
Malnutrition
Nutrition Disorders
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes
Metabolic Diseases