Home Parenteral Nutrition (HPN) Families' Mobile Distance Connections to Care Research

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mobile Technologies Assisting Patients & Family Caregivers in Healthy Living

Conditions
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Short Bowel Syndrome, Malabsorption, Malnutrition

Intervention / Treatment
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* Behavioral: HPN Group Clinic Appointments using Mobile Devices (experimental)
* Behavioral: Mobile Device Access (placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPN Group Clinic Appointments (Group 1)<br>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. | Behavioral: HPN Group Clinic Appointments using Mobile Devices (experimental)<br>* Visual meetings with geographically distant professionals and peers using a mobile device (iPad mini).<br>* Other names: Healthy Living Connections;|
| Placebo Comparator: Mobile Device Access (Group 2)<br>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. | Behavioral: Mobile Device Access (placebo)<br>* Use of iPad mini unrelated to the intervention until last contact with one connection to professionals for comparison.<br>* Other names: Placebo use of a mobile device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 Months | 
| Health Satisfaction SF-12 | Change from Baseline to 4 Months of the Health Survey SF-12v2 7-item Likert scale rating. | 4 Months | 
| Quality of Life | Change from Baseline to 4 Months of the 3-item Likert scale rating using the Cantril Ladder. | 4 Months | 
| Access to Health Care | Change from Baseline to 4 Months of the 6-item Likert scale instrument rating. | 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. | 8 Months | 
| Health Satisfaction SF-12 | Change from Baseline to 8 Months of the Health Survey SF-12v2 7-item Likert scale rating. | 8 Months | 
| Quality of Life | Change from Baseline to 8 Months of the 3-item Likert scale rating using the Cantril Ladder. | 8 Months | 
| Access to Health Care | Change from Baseline to 8 Months Change of the 6-item Likert scale instrument rating. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preparedness to Manage Home-Care | Change from Baseline to 4 Months of the caregiver strain rating with and 8-item Likert scale. | 4 Months | 
| Caregiving Burden | Change from Baseline to 4 Months of the rating from the Oberst Caregiving Burden Scale 15-item Likert scale. | 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. | 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. | 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. | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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short bowel disorder, short bowel syndrome, home parenteral nutrition, HPN, total parenteral nutrition, TPN, telehealth, telemedicine