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Completed

NCT Number: NCT02987569

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

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

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Key information

Conditions

Short Bowel Syndrome Digestive System Diseases Gastrointestinal Diseases Hyperphagia Intestinal Diseases Malabsorption Malabsorption Syndromes Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive

Age range

13 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mConnect plus mobile connections to multidisciplinary professionals & peers

Behavioral

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.

iPad use plus one mobile connections to multidisciplinary professionals & peers

Behavioral

iPad with a data plan and one professionally moderated iPad visual meeting with peers.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Teen Connections for Support From Multidisciplinary Professionals & Peers

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Dec 9, 2016
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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