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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR015743-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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12 month study testing mobile delivery of health information and connections to professionals and peers to improve health of teen/young adult HPN users.
This research study will test the effect of in-home/mobile HPN support delivered to teen and young adult home parenteral nutrition (HPN) patients and family members over handheld personal computers. Effects on health status, QoL, and fatigue will be assessed over time between groups of study subjects from the ages of 13 through 30 randomized to one of two groups. Group One (intervention group) will receive mConnect, integrated evidence-based interventions (skill-building games, restorative naps & peer support) via mobile iPad and Internet delivery plus two real-time audiovisual encrypted connections with multidisciplinary professionals and peers. Group Two (control group) will receive healthy activity information via mobile iPad and Internet delivery plus one real-time audiovisual encrypted connection with professionals and peers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group One | Experimental | Intervention |
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| Group Two | Active Comparator | Control |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mConnect plus mobile connections to multidisciplinary professionals & peers | Behavioral | mConnect is the integration of evidence-based HPN interventions delivered via professionally moderated iPad visual meetings with peers, and reinforced by HPN related skill-building games (apps) and iPad music guided short naps. |
| Measure | Description | Time Frame |
|---|---|---|
| Health Survey SF-12v2 (predicts future health services use). | Physical and mental health status from each person's perspective. 7-Item Likert | T0 (baseline data collection) |
| Quality of Life (Cantril Ladder) | Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert | T0 (baseline data collection) |
| Beck Depression Inventory-II (BDI-II) | Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item | T0 (baseline data collection) |
| Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities. | Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert | T2 (month 1-2/mConnect intervention period) |
| Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities. | Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert | T3 (month 3-4/mConnect intervention period) |
| Beck Depression Inventory-II (BDI-II) | Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item |
| Measure | Description | Time Frame |
|---|---|---|
| Preparedness (measures skills needed for independent HPN home care). | Ability to manage home-care; low score = needs home care assistance. 8-Item Likert | T0 (baseline data collection) |
| COOPS Social Support Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol E Smith, RN, PhD, FAAN | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29016235 | Background | Nelson EL, Yadrich DM, Thompson N, Wright S, Stone K, Adams N, Werkowitch M, Smith CE. Telemedicine Support Groups for Home Parenteral Nutrition Users. Nutr Clin Pract. 2017 Dec;32(6):789-798. doi: 10.1177/0884533617735527. Epub 2017 Oct 10. |
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All data is de-identified and will be reported only in aggregate.
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|
| iPad use plus one mobile connections to multidisciplinary professionals & peers | Behavioral | iPad with a data plan and one professionally moderated iPad visual meeting with peers. |
|
| T3 (4 months: change from T0/baseline) |
| Health Survey SF-12v2 (predicts future health services use). | Physical and mental health status from each person's perspective. 7-Item Likert | T3 (4 months: change from T0/baseline) |
| Quality of Life (Cantril Ladder) | Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert | T3 (4 months: change from T0/baseline) |
| Health Survey SF-12v2 (predicts future health services use). | Physical and mental health status from each person's perspective. 7-Item Likert | T4 (8 months: change from T3/4 months) |
| Quality of Life (Cantril Ladder) | Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert | T4 (8 months: change from T3/4 months) |
| Beck Depression Inventory-II (BDI-II) | Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item | T4 (8 months: change from T3/4 months) |
| Health Survey SF-12v2 (predicts future health services use). | Physical and mental health status from each person's perspective. 7-Item Likert | T5 (12 months: change from T4/8 months) |
| Quality of Life (Cantril Ladder) | Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert | T5 (12 months: change from T4/8 months) |
| Beck Depression Inventory-II (BDI-II) | Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item | T5 (12 months: change from T4/8 months) |
Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert
| T0 (baseline data collection) |
| Preparedness (measures skills needed for independent HPN home care). | Ability to manage home-care; low score = needs home care assistance. 8-Item Likert | T3 (4 months: change from T0/baseline) |
| COOPS Social Support Scale | Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert | T3 (4 months: change from T0/baseline) |
| Mobile Care Helpfulness & Willingness-to-Pay Fees for Distance Health. | Rating of Helpfulness and willingness to pay for mobile care delivery. 10-Item Likert | T4 (8 months) |
| Preparedness (measures skills needed for independent HPN home care). | Ability to manage home-care; low score = needs home care assistance. 8-Item Likert | T4 (8 months: change from T3/4 months) |
| COOPS Social Support Scale | Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert | T4 (8 months: change from T3/4 months) |
| Preparedness (measures skills needed for independent HPN home care). | Ability to manage home-care; low score = needs home care assistance. 8-Item Likert | T5 (12 months: change from T4/8 months) |
| COOPS Social Support Scale | Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert | T5 (12 months: change from T4/8 months) |
| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| D008286 | Malabsorption Syndromes |
| D044342 | Malnutrition |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009748 | Nutrition Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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