MedDataX Logo

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

NCT ID: NCT02987569

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Short Bowel Syndrome Malabsorption Malnutrition

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Home Parenteral Nutrition HPN Total Parenteral Nutrition TPN mConnect SBS short bowel disorder telehealth telemedicine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group One

Intervention

Group Type EXPERIMENTAL

mConnect plus mobile connections to multidisciplinary professionals & peers

Intervention Type 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.

Group Two

Control

Group Type ACTIVE_COMPARATOR

iPad use plus one mobile connections to multidisciplinary professionals & peers

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carol E Smith, RN, PhD, FAAN

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29016235 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01NR015743-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00004067

Identifier Type: -

Identifier Source: org_study_id