Short Bowel SyndromeNCT01900288
Home Parenteral Nutrition (HPN) Families' Mobile Distance Connections to Care Research
A study testing HPN Group Clinic Appointments using Mobile Devices (experimental) in people with Short Bowel Syndrome and Malabsorption, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to test Mobile Technologies in Assisting Patients \& Family Caregivers in Healthy Living and complex home care by connecting to information and professionals from a distance. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Short Bowel Syndrome, Malabsorption, Malnutrition
- What is being tested?
- HPN Group Clinic Appointments using Mobile Devices (experimental)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 23 Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 13 years or older total parenteral nutrition (TPN) patients/users and family members/caregivers (defined as those individuals involved in daily home HPN care)
- TPN users (also called HPN users) 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: Mobile Technologies Assisting Patients & Family Caregivers in Healthy Living
The purpose of this study is to test Mobile Technologies in Assisting Patients \& Family Caregivers in Healthy Living and complex home care by connecting to information and professionals from a distance.
Read the detailed description
HPN (Home Parenteral Nutrition) families with TPN (Total Parenteral Nutrition) users are typically geographically distant from one another (peers) as well as professional providers. Real-time mobile access to health related information, peer and professional support will be tested in this study.
- Conditions
- Short Bowel Syndrome, Malabsorption, Malnutrition
- Being tested
- HPN Group Clinic Appointments using Mobile Devices (experimental), Mobile Device Access (placebo)
- Keywords
- short bowel disorder, short bowel syndrome, home parenteral nutrition, HPN, total parenteral nutrition, TPN, 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.
HPN Group Clinic Appointments using Mobile Devices (experimental)Behavioural
Also called Healthy Living Connections
Visual meetings with geographically distant professionals and peers using a mobile device (iPad mini).
Mobile Device Access (placebo)Behavioural
Also called Placebo use of a mobile device
Use of iPad mini unrelated to the intervention until last contact with one connection to professionals for comparison.
| Study group | Role | What they receive |
|---|---|---|
| HPN Group Clinic Appointments (Group 1) | Experimental | A mobile device (iPad mini) is loaned to Group 1 subjects providing a connection to HPN Internet information for the 6 to 12 months of the study. Two scheduled times during the study period, visual connections to geographically distant professionals and peers over the iPad mini (HPN Group Clinic Appointment) will be held for approximately 1 ½ to 2 hours each time (called Healthy Living Connections).
On the iPad mini screen during the HPN Group Clinic Appointments, subjects will be able to see professionals and peers all at the same time and they will be able to see them in their home. This group will also receive electronic prompts about healthy activities. Receives: Behavioral: HPN Group Clinic Appointments using Mobile Devices (experimental) |
| Mobile Device Access (Group 2) | Placebo comparator | A mobile device (iPad mini) is loaned to Group 2 subjects providing a connection to Internet information for the 6 to12 months of the study. At the end of the study period, Group 2 subjects will have 1 scheduled time during the study to connect to professionals and peers over the iPad mini for approximately 1 ½ to 2 hours (called Healthy Living Connections) before the study concludes.
On the iPad mini screen during the placebo control group clinics, subjects will be able to see professionals and peers all at the same time and they will be able to see them in their home. This group will also receive one electronic prompt about healthy activities as a comparison control to the intervention group. Receives: Behavioral: Mobile Device Access (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement in Healthy Living Activities
Change from Baseline to 4 Months of the logged frequency of healthy living activities with a 10-item Likert scale.
Measured: 4 Months
Health Satisfaction SF-12
Change from Baseline to 4 Months of the Health Survey SF-12v2 7-item Likert scale rating.
Measured: 4 Months
Quality of Life
Change from Baseline to 4 Months of the 3-item Likert scale rating using the Cantril Ladder.
Measured: 4 Months
Access to Health Care
Change from Baseline to 4 Months of the 6-item Likert scale instrument rating.
Measured: 4 Months
Engagement in Healthy Living Activities
Change from Baseline to 8 Months of the logged frequency of healthy living activities with a 10-item Likert scale.
Measured: 8 Months
Health Satisfaction SF-12
Change from Baseline to 8 Months of the Health Survey SF-12v2 7-item Likert scale rating.
Measured: 8 Months
Quality of Life
Change from Baseline to 8 Months of the 3-item Likert scale rating using the Cantril Ladder.
Measured: 8 Months
Access to Health Care
Change from Baseline to 8 Months Change of the 6-item Likert scale instrument rating.
Measured: 8 months
Secondary outcomes (5)
Preparedness to Manage Home-Care
Change from Baseline to 4 Months of the caregiver strain rating with and 8-item Likert scale.
Measured: 4 Months
Caregiving Burden
Change from Baseline to 4 Months of the rating from the Oberst Caregiving Burden Scale 15-item Likert scale.
Measured: 4 Months
Preparedness to Manage Home-Care
Change from Baseline to 8 Months Change from Baseline to 4 Months of the caregiver strain rating with and 8-item Likert scale.
Measured: 8 Months
Caregiving Burden
Change from Baseline to 8 Months Change from Baseline to 4 Months of the rating from the Oberst Caregiving Burden Scale 15-item Likert scale.
Measured: 8 Months
Virtual Nurse Caring
At 8 months, using the Virtual Nurse Caring 20-item Likert scale instrument, caregiver's rating of perception of nurse care and needs met via mobile device is assessed.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startAug 2012
- Primary completionDec 2015
- Study completion23 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Carol Smith, RN PhD FAAN, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900288
- Sponsor's protocol ID
- 13337
- Other IDs
- R01EB015911
- Status last verified
- Jan 2017
- First submitted
- 11 Jul 2013
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Technologies Assisting Patients & Family Caregivers in Healthy Living
- ClinicalTrials.gov ID
- NCT01900288
- Acronym / sponsor ID
- 13337
- Conditions
- Short Bowel Syndrome, Malabsorption, Malnutrition
- Keywords
- short bowel disorder, short bowel syndrome, home parenteral nutrition, HPN, total parenteral nutrition, TPN, telehealth, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- Aug 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- 23 Dec 2016 (actual)
- First posted
- 16 Jul 2013 (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.
The purpose of this study is to test Mobile Technologies in Assisting Patients \& Family Caregivers in Healthy Living and complex home care by connecting to information and professionals from a distance.
Detailed description
HPN (Home Parenteral Nutrition) families with TPN (Total Parenteral Nutrition) users are typically geographically distant from one another (peers) as well as professional providers. Real-time mobile access to health related information, peer and professional support will be tested in this study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPN Group Clinic Appointments (Group 1) | Experimental | Behavioral: HPN Group Clinic Appointments using Mobile Devices (experimental)A mobile device (iPad mini) is loaned to Group 1 subjects providing a connection to HPN Internet information for the 6 to 12 months of the study. Two scheduled times during the study period, visual connections to geographically distant professionals and peers over the iPad mini (HPN Group Clinic Appointment) will be held for approximately 1 ½ to 2 hours each time (called Healthy Living Connections). On the iPad mini screen during the HPN Group Clinic Appointments, subjects will be able to see professionals and peers all at the same time and they will be able to see them in their home. This group will also receive electronic prompts about healthy activities. |
| Mobile Device Access (Group 2) | Placebo comparator | Behavioral: Mobile Device Access (placebo)A mobile device (iPad mini) is loaned to Group 2 subjects providing a connection to Internet information for the 6 to12 months of the study. At the end of the study period, Group 2 subjects will have 1 scheduled time during the study to connect to professionals and peers over the iPad mini for approximately 1 ½ to 2 hours (called Healthy Living Connections) before the study concludes. On the iPad mini screen during the placebo control group clinics, subjects will be able to see professionals and peers all at the same time and they will be able to see them in their home. This group will also receive one electronic prompt about healthy activities as a comparison control to the intervention group. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 13 years or older total parenteral nutrition (TPN) patients/users and family members/caregivers (defined as those individuals involved in daily home HPN care)
- TPN users (also called HPN users) 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 |
|---|---|---|
| HPN Group Clinic Appointments using Mobile Devices (experimental)Also: Healthy Living ConnectionsVisual meetings with geographically distant professionals and peers using a mobile device (iPad mini). | Behavioural | HPN Group Clinic Appointments (Group 1) |
| Mobile Device Access (placebo)Also: Placebo use of a mobile deviceUse of iPad mini unrelated to the intervention until last contact with one connection to professionals for comparison. | Behavioural | Mobile Device Access (Group 2) |
Primary outcome
Engagement in Healthy Living Activities
Time frame: 4 Months
Change from Baseline to 4 Months of the logged frequency of healthy living activities with a 10-item Likert scale.
Health Satisfaction SF-12
Time frame: 4 Months
Change from Baseline to 4 Months of the Health Survey SF-12v2 7-item Likert scale rating.
Quality of Life
Time frame: 4 Months
Change from Baseline to 4 Months of the 3-item Likert scale rating using the Cantril Ladder.
Access to Health Care
Time frame: 4 Months
Change from Baseline to 4 Months of the 6-item Likert scale instrument rating.
Engagement in Healthy Living Activities
Time frame: 8 Months
Change from Baseline to 8 Months of the logged frequency of healthy living activities with a 10-item Likert scale.
Health Satisfaction SF-12
Time frame: 8 Months
Change from Baseline to 8 Months of the Health Survey SF-12v2 7-item Likert scale rating.
Quality of Life
Time frame: 8 Months
Change from Baseline to 8 Months of the 3-item Likert scale rating using the Cantril Ladder.
Access to Health Care
Time frame: 8 months
Change from Baseline to 8 Months Change of the 6-item Likert scale instrument rating.
5 secondary outcomes
Preparedness to Manage Home-Care
Time frame: 4 Months
Caregiving Burden
Time frame: 4 Months
Preparedness to Manage Home-Care
Time frame: 8 Months
Caregiving Burden
Time frame: 8 Months
Virtual Nurse Caring
Time frame: 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 27 Jan 2017.
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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 Smith, RN PhD FAAN principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPN Group Clinic Appointments using Mobile Devices (experimental) 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 27 Jan 2017. 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. Some participants in this study may receive a placebo. 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?
Engagement in Healthy Living Activities (time frame: 4 Months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2017.