An interventional study of mConnect plus mobile connections to multidisciplinary professionals & peers and iPad use plus one mobile connections to multidisciplinary professionals & peers in Short Bowel Syndrome, Malabsorption and Malnutrition, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 13 Years to 30 Years. Per ClinicalTrials.gov, last updated 2020-12-02.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Health services research
12 month study testing mobile delivery of health information and connections to professionals and peers to improve health of teen/young adult HPN users.
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.
159 studies on the registry are indexed under Short Bowel Syndrome; 24 are open to participants now.
This study's enrollment of 83 is above the median of 21 across 108 interventional studies indexed under Short Bowel Syndrome.
Browse Short Bowel Syndrome studies →University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention
Behavioral: mConnect plus mobile connections to multidisciplinary professionals & peers
Control
Behavioral: iPad use plus one 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.
iPad with a data plan and one professionally moderated iPad visual meeting with peers.
Health Survey SF-12v2 (predicts future health services use).
Physical and mental health status from each person's perspective. 7-Item Likert
Time frame: T0 (baseline data collection)
Quality of Life (Cantril Ladder)
Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
Time frame: T0 (baseline data collection)
Beck Depression Inventory-II (BDI-II)
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
Time frame: T0 (baseline data collection)
Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.
Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert
Time frame: T2 (month 1-2/mConnect intervention period)
Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.
Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert
Time frame: T3 (month 3-4/mConnect intervention period)
Beck Depression Inventory-II (BDI-II)
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
Time frame: T3 (4 months: change from T0/baseline)
Health Survey SF-12v2 (predicts future health services use).
Physical and mental health status from each person's perspective. 7-Item Likert
Time frame: T3 (4 months: change from T0/baseline)
Quality of Life (Cantril Ladder)
Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
Time frame: T3 (4 months: change from T0/baseline)
Health Survey SF-12v2 (predicts future health services use).
Physical and mental health status from each person's perspective. 7-Item Likert
Time frame: T4 (8 months: change from T3/4 months)
Quality of Life (Cantril Ladder)
Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
Time frame: T4 (8 months: change from T3/4 months)
Beck Depression Inventory-II (BDI-II)
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
Time frame: T4 (8 months: change from T3/4 months)
Health Survey SF-12v2 (predicts future health services use).
Physical and mental health status from each person's perspective. 7-Item Likert
Time frame: T5 (12 months: change from T4/8 months)
Quality of Life (Cantril Ladder)
Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
Time frame: T5 (12 months: change from T4/8 months)
Beck Depression Inventory-II (BDI-II)
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
Time frame: T5 (12 months: change from T4/8 months)
Preparedness (measures skills needed for independent HPN home care).
Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
Time frame: T0 (baseline data collection)
COOPS Social Support Scale
Ratings on having others who help, listen \& provide tangible assistance support. 13-Item Likert
Time frame: T0 (baseline data collection)
Preparedness (measures skills needed for independent HPN home care).
Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
Time frame: T3 (4 months: change from T0/baseline)
COOPS Social Support Scale
Ratings on having others who help, listen \& provide tangible assistance support. 13-Item Likert
Time frame: T3 (4 months: change from T0/baseline)
Mobile Care Helpfulness & Willingness-to-Pay Fees for Distance Health.
Rating of Helpfulness and willingness to pay for mobile care delivery. 10-Item Likert
Time frame: T4 (8 months)
Preparedness (measures skills needed for independent HPN home care).
Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
Time frame: T4 (8 months: change from T3/4 months)
COOPS Social Support Scale
Ratings on having others who help, listen \& provide tangible assistance support. 13-Item Likert
Time frame: T4 (8 months: change from T3/4 months)
Preparedness (measures skills needed for independent HPN home care).
Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
Time frame: T5 (12 months: change from T4/8 months)
COOPS Social Support Scale
Ratings on having others who help, listen \& provide tangible assistance support. 13-Item Likert
Time frame: T5 (12 months: change from T4/8 months)
Plan to share: No — All data is de-identified and will be reported only in aggregate.
The record gives a start of Jul 2016, a primary completion of Dec 2019 and a completion of Jun 2020. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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