Home Parenteral NutritionNCT00315094
Technological Home Care: Improving HPN Care With Videophone And Internet Education
A study testing Caregiving support interventions (FamTechCare) in people with Home Parenteral Nutrition, run by University of Kansas at 1 site in United States.
Trial summary
The purpose of this study is to help people with home parenteral nutrition (HPN) to avoid infections and feelings of depression or fatigue and to test how their health and quality of life change over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Home Parenteral Nutrition
- What is being tested?
- Caregiving support interventions (FamTechCare)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Nov 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Caregivers of HPN patients short- or long-term HPN
- able to participate in writing and other intervention activities
- able to speak/read/write English or Spanish
Who cannot join
- Patients with psychiatric disorders (e.g., schizophrenia, hallucinations) and physical disabilities that prevent use of intervention
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: Prevention of Home Parenteral Nutrition (HPN) Infection, Depression and Improving Caregiving Problem Solving
The purpose of this study is to help people with home parenteral nutrition (HPN) to avoid infections and feelings of depression or fatigue and to test how their health and quality of life change over time. Another purpose is to test the nurse teaching sessions and the method of obtaining support from the peer partner through videophone.
Read the detailed description
Aim #1 Hypothesis
- Dyad (patient-caregiver) participation in health care management and problem-solving method use with professionals will be greater in the experimental group than the control group
- Dyad reactive depression will be lower in the experimental group than the control group
- Dyad quality of life will be higher in the experimental group than the control group
- Dyad health status scores will be higher and the dyad sleepiness scale will be lower in experimental group than the control group
- Dyad Health Services Use will be lower in the experimental group than the control group
- Catheter-related infections will be lower in the experimental than control patients
Aim #2 Hypotheses:
- What is the cost of using the FamTechCare system compared to traditional care?
- Is there a difference between efficiency scores of the experimental and control groups intervention, boosters and relative to dyads long-term health services use at 24 months?
- What are the relationships among patient outcome variables and caregivers' rating of virtual nurse caring and caregiver adaption?
- What are the relationships among use of FamTechCare, dyad participation in health care management scale score and dyad access to the Internet Weighted Score?
- Conditions
- Home Parenteral Nutrition
- Being tested
- Caregiving support interventions (FamTechCare)
- Keywords
- home parenteral nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiving support interventions (FamTechCare)Behavioural
One set of combined interventions to be tested in this study are nursing interventions for the prevention of catheter-related infection, reactive depression, and HPN home care problem-solving. The other set of combined interventions are for increasing social support and use of a short nap to reduce daily fatigue. Information about all the interventions were incorporated into Internet formats as a booster for reinforcement.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Caregiving support interventions (FamTechCare) |
| 2 | No intervention | After a control period, this group crosses over to experimental interventions (Arm 1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter related infection, depression, problem-solving and quality of life scores.
Measured: Experimental arm at T6, Control arm at T9.
Secondary outcomes (1)
Ratings of virtual nurse caring
Measured: Experimental arm at T6, Control arm at T9.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionJul 2010
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Home Parenteral NutritionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Carol Smith, RN, PhD, FAAN, University of Kansas
- Investigators
- Carol E Smith, PhD, RN, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315094
- Sponsor's protocol ID
- 9655
- Status last verified
- Feb 2012
- First submitted
- 13 Apr 2006
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Home Parenteral Nutrition (HPN) Infection, Depression and Improving Caregiving Problem Solving
- ClinicalTrials.gov ID
- NCT00315094
- Acronym / sponsor ID
- 9655
- Conditions
- Home Parenteral Nutrition
- Keywords
- home parenteral nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Apr 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 17 Apr 2006 (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 help people with home parenteral nutrition (HPN) to avoid infections and feelings of depression or fatigue and to test how their health and quality of life change over time. Another purpose is to test the nurse teaching sessions and the method of obtaining support from the peer partner through videophone.
Detailed description
Aim #1 Hypothesis
- Dyad (patient-caregiver) participation in health care management and problem-solving method use with professionals will be greater in the experimental group than the control group
- Dyad reactive depression will be lower in the experimental group than the control group
- Dyad quality of life will be higher in the experimental group than the control group
- Dyad health status scores will be higher and the dyad sleepiness scale will be lower in experimental group than the control group
- Dyad Health Services Use will be lower in the experimental group than the control group
- Catheter-related infections will be lower in the experimental than control patients
Aim #2 Hypotheses:
- What is the cost of using the FamTechCare system compared to traditional care?
- Is there a difference between efficiency scores of the experimental and control groups intervention, boosters and relative to dyads long-term health services use at 24 months?
- What are the relationships among patient outcome variables and caregivers' rating of virtual nurse caring and caregiver adaption?
- What are the relationships among use of FamTechCare, dyad participation in health care management scale score and dyad access to the Internet Weighted Score?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Caregiving support interventions (FamTechCare) |
| 2 | No intervention | –After a control period, this group crosses over to experimental interventions (Arm 1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Caregivers of HPN patients short- or long-term HPN
- able to participate in writing and other intervention activities
- able to speak/read/write English or Spanish
Key exclusion criteria (1 listed)
- Patients with psychiatric disorders (e.g., schizophrenia, hallucinations) and physical disabilities that prevent use of intervention
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 |
|---|---|---|
| Caregiving support interventions (FamTechCare)One set of combined interventions to be tested in this study are nursing interventions for the prevention of catheter-related infection, reactive depression, and HPN home care problem-solving. The other set of combined interventions are for increasing social support and use of a short nap to reduce daily fatigue. Information about all the interventions were incorporated into Internet formats as a booster for reinforcement. | Behavioural | 1 |
Primary outcome
Catheter related infection, depression, problem-solving and quality of life scores.
Time frame: Experimental arm at T6, Control arm at T9.
1 secondary outcome
Ratings of virtual nurse caring
Time frame: Experimental arm at T6, Control arm at T9.
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 28 Feb 2012.
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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 E Smith, PhD, RN principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiving support interventions (FamTechCare) in people with Home Parenteral Nutrition, run by University of Kansas 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 1 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 28 Feb 2012. 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. 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?
Catheter related infection, depression, problem-solving and quality of life scores. (time frame: Experimental arm at T6, Control arm at T9.). 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 28 Feb 2012.