Short Bowel SyndromeNCT02987569
Teen and Young Adult Connections for Support From Multidisciplinary Professionals & Peers
A study testing mConnect plus mobile connections to multidisciplinary professionals & peers and iPad use plus one mobile connections to multidisciplinary professionals & peers in people with Short Bowel Syndrome and Malabsorption, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 30 years
- Conditions the study is for
- Short Bowel Syndrome, Malabsorption, Malnutrition
- What is being tested?
- mConnect plus mobile connections to multidisciplinary professionals & peers and iPad use plus one mobile connections to multidisciplinary professionals & peers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Teen 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.
Read the 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.
- Conditions
- Short Bowel Syndrome, Malabsorption, Malnutrition
- Being tested
- mConnect plus mobile connections to multidisciplinary professionals & peers, iPad use plus one mobile connections to multidisciplinary professionals & peers
- Keywords
- Home Parenteral Nutrition, HPN, Total Parenteral Nutrition, TPN, mConnect, SBS, short bowel disorder, telehealth, telemedicine
- Medical subject headings
- Short Bowel Syndrome, Malabsorption Syndromes, Malnutrition, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mConnect plus mobile connections to multidisciplinary professionals & peersBehavioural
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 & peersBehavioural
iPad with a data plan and one professionally moderated iPad visual meeting with peers.
| Study group | Role | What they receive |
|---|---|---|
| Group One | Experimental | Intervention Receives: Behavioral: mConnect plus mobile connections to multidisciplinary professionals & peers |
| Group Two | Active comparator | Control Receives: Behavioral: iPad use plus one mobile connections to multidisciplinary professionals & peers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Survey SF-12v2 (predicts future health services use).
Physical and mental health status from each person's perspective. 7-Item Likert
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: T5 (12 months: change from T4/8 months)
Secondary outcomes (9)
Preparedness (measures skills needed for independent HPN home care).
Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
Measured: T0 (baseline data collection)
COOPS Social Support Scale
Ratings on having others who help, listen \& provide tangible assistance support. 13-Item Likert
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: T5 (12 months: change from T4/8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2019
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Carol E Smith, RN, PhD, FAAN, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987569
- Sponsor's protocol ID
- STUDY00004067
- Other IDs
- R01NR015743-01A1
- Status last verified
- Nov 2020
- First submitted
- 6 Dec 2016
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: All data is de-identified and will be reported only in aggregate.
Publications
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.
PubMed 29016235
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teen Connections for Support From Multidisciplinary Professionals & Peers
- ClinicalTrials.gov ID
- NCT02987569
- Acronym / sponsor ID
- STUDY00004067
- Conditions
- Short Bowel Syndrome, Malabsorption, Malnutrition
- Keywords
- Home Parenteral Nutrition, HPN, Total Parenteral Nutrition, TPN, mConnect, SBS, short bowel disorder, telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jul 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
12 month study testing mobile delivery of health information and connections to professionals and peers to improve health of teen/young adult HPN users.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group One | Experimental | Behavioral: mConnect plus mobile connections to multidisciplinary professionals & peersIntervention |
| Group Two | Active comparator | Behavioral: iPad use plus one mobile connections to multidisciplinary professionals & peersControl |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mConnect plus mobile connections to multidisciplinary professionals & peersmConnect 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. | Behavioural | Group One |
| iPad use plus one mobile connections to multidisciplinary professionals & peersiPad with a data plan and one professionally moderated iPad visual meeting with peers. | Behavioural | Group Two |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
9 secondary outcomes
Preparedness (measures skills needed for independent HPN home care).
Time frame: T0 (baseline data collection)
COOPS Social Support Scale
Time frame: T0 (baseline data collection)
Preparedness (measures skills needed for independent HPN home care).
Time frame: T3 (4 months: change from T0/baseline)
COOPS Social Support Scale
Time frame: T3 (4 months: change from T0/baseline)
Mobile Care Helpfulness & Willingness-to-Pay Fees for Distance Health.
Time frame: T4 (8 months)
Preparedness (measures skills needed for independent HPN home care).
Time frame: T4 (8 months: change from T3/4 months)
COOPS Social Support Scale
Time frame: T4 (8 months: change from T3/4 months)
Preparedness (measures skills needed for independent HPN home care).
Time frame: T5 (12 months: change from T4/8 months)
COOPS Social Support Scale
Time frame: T5 (12 months: change from T4/8 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Background: PubMed 29016235Nelson 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.
- Individual participant dataSharing planned: No. All data is de-identified and will be reported only in aggregate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol E Smith, RN, PhD, FAAN principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mConnect plus mobile connections to multidisciplinary professionals & peers and iPad use plus one mobile connections to multidisciplinary professionals & peers in people with Short Bowel Syndrome and Malabsorption, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Survey SF-12v2 (predicts future health services use). (time frame: T0 (baseline data collection)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02987569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.