Mobile Technologies Assisting Patients & Family Caregivers in Healthy Living
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Engagement in Healthy Living Activities
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
HPN Group Clinic Appointments (Group 1)
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.
Intervention: HPN Group Clinic Appointments using Mobile Devices (experimental) (Behavioral)
Mobile Device Access (Group 2)
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.
Intervention: Mobile Device Access (placebo) (Behavioral)
Outcomes
Primary Outcomes
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.
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.
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.
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.
Secondary Outcomes
- Virtual Nurse Caring(8 months)
- Caregiving Burden(8 Months)
- Preparedness to Manage Home-Care(8 Months)
- Preparedness to Manage Home-Care(4 Months)
- Caregiving Burden(4 Months)