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Completed

NCT Number: NCT01900288

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

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.

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Key information

Conditions

Short Bowel Syndrome Digestive System Diseases Gastrointestinal Diseases Hyperphagia Intestinal Diseases Malabsorption Malabsorption Syndromes Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HPN Group Clinic Appointments using Mobile Devices (experimental)

Behavioral

Visual meetings with geographically distant professionals and peers using a mobile device (iPad mini).

Other names: Healthy Living Connections

Mobile Device Access (placebo)

Behavioral

Use of iPad mini unrelated to the intervention until last contact with one connection to professionals for comparison.

Other names: Placebo use of a mobile device

Primary outcomes

  1. 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.

  2. 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.

  3. Quality of Life

    Time frame: 4 Months

    Change from Baseline to 4 Months of the 3-item Likert scale rating using the Cantril Ladder.

  4. Access to Health Care

    Time frame: 4 Months

    Change from Baseline to 4 Months of the 6-item Likert scale instrument rating.

  5. 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.

  6. 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.

  7. Quality of Life

    Time frame: 8 Months

    Change from Baseline to 8 Months of the 3-item Likert scale rating using the Cantril Ladder.

  8. Access to Health Care

    Time frame: 8 months

    Change from Baseline to 8 Months Change of the 6-item Likert scale instrument rating.

Secondary outcomes

  1. Preparedness to Manage Home-Care

    Time frame: 4 Months

    Change from Baseline to 4 Months of the caregiver strain rating with and 8-item Likert scale.

  2. Caregiving Burden

    Time frame: 4 Months

    Change from Baseline to 4 Months of the rating from the Oberst Caregiving Burden Scale 15-item Likert scale.

  3. Preparedness to Manage Home-Care

    Time frame: 8 Months

    Change from Baseline to 8 Months Change from Baseline to 4 Months of the caregiver strain rating with and 8-item Likert scale.

  4. Caregiving Burden

    Time frame: 8 Months

    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.

  5. Virtual Nurse Caring

    Time frame: 8 months

    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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Official study title

Mobile Technologies Assisting Patients & Family Caregivers in Healthy Living

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jul 16, 2013
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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