Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-03-05 @ 1:55 AM
Study NCT ID:
NCT02987569
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2016-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Teen and Young Adult Connections for Support From Multidisciplinary Professionals & Peers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012778', 'term': 'Short Bowel Syndrome'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-30', 'studyFirstSubmitDate': '2016-12-06', 'studyFirstSubmitQcDate': '2016-12-08', 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Survey SF-12v2 (predicts future health services use).', 'timeFrame': 'T0 (baseline data collection)', 'description': "Physical and mental health status from each person's perspective. 7-Item Likert"}, {'measure': 'Quality of Life (Cantril Ladder)', 'timeFrame': 'T0 (baseline data collection)', 'description': 'Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert'}, {'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': 'T0 (baseline data collection)', 'description': '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'}, {'measure': 'Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.', 'timeFrame': 'T2 (month 1-2/mConnect intervention period)', 'description': 'Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert'}, {'measure': 'Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.', 'timeFrame': 'T3 (month 3-4/mConnect intervention period)', 'description': 'Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert'}, {'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': 'T3 (4 months: change from T0/baseline)', 'description': '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'}, {'measure': 'Health Survey SF-12v2 (predicts future health services use).', 'timeFrame': 'T3 (4 months: change from T0/baseline)', 'description': "Physical and mental health status from each person's perspective. 7-Item Likert"}, {'measure': 'Quality of Life (Cantril Ladder)', 'timeFrame': 'T3 (4 months: change from T0/baseline)', 'description': 'Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert'}, {'measure': 'Health Survey SF-12v2 (predicts future health services use).', 'timeFrame': 'T4 (8 months: change from T3/4 months)', 'description': "Physical and mental health status from each person's perspective. 7-Item Likert"}, {'measure': 'Quality of Life (Cantril Ladder)', 'timeFrame': 'T4 (8 months: change from T3/4 months)', 'description': 'Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert'}, {'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': 'T4 (8 months: change from T3/4 months)', 'description': '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'}, {'measure': 'Health Survey SF-12v2 (predicts future health services use).', 'timeFrame': 'T5 (12 months: change from T4/8 months)', 'description': "Physical and mental health status from each person's perspective. 7-Item Likert"}, {'measure': 'Quality of Life (Cantril Ladder)', 'timeFrame': 'T5 (12 months: change from T4/8 months)', 'description': 'Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert'}, {'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': 'T5 (12 months: change from T4/8 months)', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Preparedness (measures skills needed for independent HPN home care).', 'timeFrame': 'T0 (baseline data collection)', 'description': 'Ability to manage home-care; low score = needs home care assistance. 8-Item Likert'}, {'measure': 'COOPS Social Support Scale', 'timeFrame': 'T0 (baseline data collection)', 'description': 'Ratings on having others who help, listen \\& provide tangible assistance support. 13-Item Likert'}, {'measure': 'Preparedness (measures skills needed for independent HPN home care).', 'timeFrame': 'T3 (4 months: change from T0/baseline)', 'description': 'Ability to manage home-care; low score = needs home care assistance. 8-Item Likert'}, {'measure': 'COOPS Social Support Scale', 'timeFrame': 'T3 (4 months: change from T0/baseline)', 'description': 'Ratings on having others who help, listen \\& provide tangible assistance support. 13-Item Likert'}, {'measure': 'Mobile Care Helpfulness & Willingness-to-Pay Fees for Distance Health.', 'timeFrame': 'T4 (8 months)', 'description': 'Rating of Helpfulness and willingness to pay for mobile care delivery. 10-Item Likert'}, {'measure': 'Preparedness (measures skills needed for independent HPN home care).', 'timeFrame': 'T4 (8 months: change from T3/4 months)', 'description': 'Ability to manage home-care; low score = needs home care assistance. 8-Item Likert'}, {'measure': 'COOPS Social Support Scale', 'timeFrame': 'T4 (8 months: change from T3/4 months)', 'description': 'Ratings on having others who help, listen \\& provide tangible assistance support. 13-Item Likert'}, {'measure': 'Preparedness (measures skills needed for independent HPN home care).', 'timeFrame': 'T5 (12 months: change from T4/8 months)', 'description': 'Ability to manage home-care; low score = needs home care assistance. 8-Item Likert'}, {'measure': 'COOPS Social Support Scale', 'timeFrame': 'T5 (12 months: change from T4/8 months)', 'description': 'Ratings on having others who help, listen \\& provide tangible assistance support. 13-Item Likert'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Home Parenteral Nutrition', 'HPN', 'Total Parenteral Nutrition', 'TPN', 'mConnect', 'SBS', 'short bowel disorder', 'telehealth', 'telemedicine'], 'conditions': ['Short Bowel Syndrome', 'Malabsorption', 'Malnutrition']}, 'referencesModule': {'references': [{'pmid': '29016235', 'type': 'BACKGROUND', 'citation': 'Nelson EL, Yadrich DM, Thompson N, Wright S, Stone K, Adams N, Werkowitch M, Smith CE. Telemedicine Support Groups for Home Parenteral Nutrition Users. Nutr Clin Pract. 2017 Dec;32(6):789-798. doi: 10.1177/0884533617735527. Epub 2017 Oct 10.'}]}, 'descriptionModule': {'briefSummary': '12 month study testing mobile delivery of health information and connections to professionals and peers to improve health of teen/young adult HPN users.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Total parenteral nutrition (TPN) patients/users and family members/caregivers (defined as those individuals involved in daily home HPN care) age 13 and older\n* TPN users (also called HPN users) ages 13 through 30 must be receiving intravenous nutrition for a non-malignant short bowel disorder\n* Read, write, speak English and provide informed consent\n* Be able to participate in group clinic visits\n\nExclusion Criteria:\n\n* Enteral nutrition dependency only\n* Less than 13 years of age\n* 13 through 17 years of age without parental consent\n* Currently enrolled in an intervention study or HPN management program\n* Severe cognitive impairment\n* Disability disorders (e.g. blindness which cannot be accommodated for active participation in the group clinics'}, 'identificationModule': {'nctId': 'NCT02987569', 'briefTitle': 'Teen and Young Adult Connections for Support From Multidisciplinary Professionals & Peers', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Teen Connections for Support From Multidisciplinary Professionals & Peers', 'orgStudyIdInfo': {'id': 'STUDY00004067'}, 'secondaryIdInfos': [{'id': 'R01NR015743-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01NR015743-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group One', 'description': 'Intervention', 'interventionNames': ['Behavioral: mConnect plus mobile connections to multidisciplinary professionals & peers']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Two', 'description': 'Control', 'interventionNames': ['Behavioral: iPad use plus one mobile connections to multidisciplinary professionals & peers']}], 'interventions': [{'name': 'mConnect plus mobile connections to multidisciplinary professionals & peers', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Group One']}, {'name': 'iPad use plus one mobile connections to multidisciplinary professionals & peers', 'type': 'BEHAVIORAL', 'description': 'iPad with a data plan and one professionally moderated iPad visual meeting with peers.', 'armGroupLabels': ['Group Two']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Carol E Smith, RN, PhD, FAAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All data is de-identified and will be reported only in aggregate.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}