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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR015737-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The purpose of this study is to use technology to improve symptom status and ultimately improve patient centered outcomes in people living with HIV/AIDS (PLWHA). The primary purpose of the intervention (VIP-HANA) is to improve symptom status. The investigators hypothesize that VIP-HANA will improve symptom frequency and intensity.
As PLWHA age, they are developing chronic illnesses and co-morbid conditions that are often seen in older HIV negative patients. HANA conditions (e.g., cardiovascular disease, liver disease, diabetes, and asthma) are becoming more common as PLWHA age.
An individual's ability to identify and self-manage symptoms of HIV illness has been shown to improve patient outcomes and quality of life. The investigators will develop and pilot test the Video Information Provider (VIP), a web application (app) that delivered HIV-related symptom self-care strategies for PLWHA for 13 common (non-HANA) HIV/AIDS symptoms. There is a need to identify the symptom experience of PLWHA with HANA conditions.
The aim is to compare the efficacy of VIP-HANA to a control arm for ameliorating symptom frequency and intensity and secondary health outcomes in 100 PLWHA with HANA conditions over 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | VIP app that delivers HIV-related symptom strategies |
|
| Control | Sham Comparator | VIP app without HIV-related symptom strategies |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIP app without HIV-related symptom strategies. | Behavioral | The control group will receive the VIP app without HIV-related symptom strategies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Burden Score | The Symptom Burden Score is an expanded version of the 20-item HIV symptom index. The score is calculated for the 28 most common symptoms in persons living with HIV. Each symptom is given a score ranging from 0 to 4 with the scores indicating the following: 0 (not experienced) , 1 (It doesn't bother me), 2 (It bothers me a little), 3 (It bothers me), or 4 (It bothers me a lot). The higher the score (closer to 4), the greater the symptom burden (worse outcome). | Baseline, 3 months and 6 months; period 1 = 1-6 weeks (baseline), period 2 = 6-18 weeks (3 months), period 3 = >18 weeks (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Each of the 7 domains has four 5-level items (i.e., 16 decrements each). In addition to these items, pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain. Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. T-scores can be estimated using scoring tables listed in the PROMIS manuals. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score on SF-12 | 12-Item Medical Outcomes Study Short Form (SF-12) is a health survey to measure health-related quality of life. | 3 months and 6 months |
| Score on Engagement With Health Care Provider Scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Schnall, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University School for Nursing | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36696639 | Derived | Gordian-Arroyo A, Reame N, Gutierrez J, Liu J, Ganzhorn S, Igwe KC, Laing K, Schnall R. Do correlates of white matter features differ between older men and women living with human immunodeficiency virus? Menopause. 2023 Feb 1;30(2):149-155. doi: 10.1097/GME.0000000000002102. Epub 2022 Nov 20. | |
| 32538796 | Derived | Cho H, Porras T, Flynn G, Schnall R. Usability of a Consumer Health Informatics Tool Following Completion of a Clinical Trial: Focus Group Study. J Med Internet Res. 2020 Jun 15;22(6):e17708. doi: 10.2196/17708. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | VIP app that delivers HIV-related symptom strategies VIP app that delivers HIV-related symptom strategies.: The Intervention group will receive the VIP app that delivers HIV-related symptom strategies |
| FG001 | Control | VIP app without HIV-related symptom strategies VIP app without HIV-related symptom strategies.: The control group will receive the VIP app without HIV-related symptom strategies |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | VIP app that delivers HIV-related symptom strategies VIP app that delivers HIV-related symptom strategies.: The Intervention group will receive the VIP app that delivers HIV-related symptom strategies |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Symptom Burden Score | The Symptom Burden Score is an expanded version of the 20-item HIV symptom index. The score is calculated for the 28 most common symptoms in persons living with HIV. Each symptom is given a score ranging from 0 to 4 with the scores indicating the following: 0 (not experienced) , 1 (It doesn't bother me), 2 (It bothers me a little), 3 (It bothers me), or 4 (It bothers me a lot). The higher the score (closer to 4), the greater the symptom burden (worse outcome). | The statistical analysis defined the time points into 3 periods to correlate with the baseline, 3-month, and 6-month visits. Not all participants completed the symptom burden scale and therefore did not align within the 3 designated periods. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months and 6 months; period 1 = 1-6 weeks (baseline), period 2 = 6-18 weeks (3 months), period 3 = >18 weeks (6 months) |
|
Adverse event data was collected over a 1 year time period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | VIP app that delivers HIV-related symptom strategies VIP app that delivers HIV-related symptom strategies.: The Intervention group will receive the VIP app that delivers HIV-related symptom strategies |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rebecca Schnall | Columbia University School of Nursing | 212-342-6886 | rb897@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2018 | Oct 22, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| VIP app that delivers HIV-related symptom strategies. | Behavioral | The Intervention group will receive the VIP app that delivers HIV-related symptom strategies |
|
| Baseline, 3 months, and 6 months |
Engagement with Health Care Provide scale is a 13-item scale in which subjects rate their interactions with their health care providers on a four-point scale with 1=always true and 4=never true. A total score can be calculated to create a possible range of 13-52. A low score (closer to 13) indicates greater provider engagement between the patient and provider.
| Baseline, 3 months, and 6 months |
| Score of the VAS | The Visual Analogue Scale (VAS) measures adherence to antiretroviral therapy (ART). VAS asks subjects to indicate a point on a line that shows their best guess about how much of each drug they have taken. 0% means they have taken no drug, 50% means they have taken half their drugs, and 100% means they have taken every single dose. | Baseline, 3 months, and 6 months |
| Score on Fried's Frailty Phenotype | Fried's frailty phenotype is a combination of five scores: weight loss in the last year, exhaustion, physical activity, walk time for a 15 foot interval, and grip strength. The frailty condition is defined as meeting the definition of frailty for at least 3 of the listed scores. | Baseline, 3 months, and 6 months |
| Withdrawal by Subject |
|
VIP app without HIV-related symptom strategies
VIP app without HIV-related symptom strategies.: The control group will receive the VIP app without HIV-related symptom strategies
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
VIP app that delivers HIV-related symptom strategies
VIP app that delivers HIV-related symptom strategies.: The Intervention group will receive the VIP app that delivers HIV-related symptom strategies
| OG001 | Control | VIP app without HIV-related symptom strategies VIP app without HIV-related symptom strategies.: The control group will receive the VIP app without HIV-related symptom strategies |
|
|
|
| Secondary | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Each of the 7 domains has four 5-level items (i.e., 16 decrements each). In addition to these items, pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain. Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. T-scores can be estimated using scoring tables listed in the PROMIS manuals. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. | Not all participants completed the scale at 3 months and 6 months because they did not show up to their 3-month and 6-month follow-up visit. Some participants also did not answer all of the questions within the scale to produce a valid t-score, and were thus excluded from the analysis. | Posted | Mean | Standard Deviation | T-Score | Baseline, 3 months, and 6 months |
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|
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| Other Pre-specified | Change in Score on SF-12 | 12-Item Medical Outcomes Study Short Form (SF-12) is a health survey to measure health-related quality of life. | Not Posted | 3 months and 6 months | Participants |
| Other Pre-specified | Score on Engagement With Health Care Provider Scale | Engagement with Health Care Provide scale is a 13-item scale in which subjects rate their interactions with their health care providers on a four-point scale with 1=always true and 4=never true. A total score can be calculated to create a possible range of 13-52. A low score (closer to 13) indicates greater provider engagement between the patient and provider. | Not all participants completed the scale at 3 months and 6 months because they did not show up to their 3-month and 6-month follow-up visit. Some participants also did not answer all of the questions within the scale to produce a score between 13 and 52, and were thus excluded from the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, and 6 months |
|
|
|
| Other Pre-specified | Score of the VAS | The Visual Analogue Scale (VAS) measures adherence to antiretroviral therapy (ART). VAS asks subjects to indicate a point on a line that shows their best guess about how much of each drug they have taken. 0% means they have taken no drug, 50% means they have taken half their drugs, and 100% means they have taken every single dose. | Not all participants completed the scale at 3 months and 6 months because they did not show up to their 3-month and 6-month follow-up visit. Some participants also did not answer the question and left it blank, thus excluded from the analysis. | Posted | Mean | Standard Deviation | percentage of medication | Baseline, 3 months, and 6 months |
|
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| Other Pre-specified | Score on Fried's Frailty Phenotype | Fried's frailty phenotype is a combination of five scores: weight loss in the last year, exhaustion, physical activity, walk time for a 15 foot interval, and grip strength. The frailty condition is defined as meeting the definition of frailty for at least 3 of the listed scores. | Not all participants showed up to their 3-month and 6-month follow-up visit and therefore did not complete any of the frailty measures. These individuals were excluded from the analysis. | Posted | Count of Participants | Participants | Baseline, 3 months, and 6 months |
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|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Control | VIP app without HIV-related symptom strategies VIP app without HIV-related symptom strategies.: The control group will receive the VIP app without HIV-related symptom strategies | 0 | 50 | 0 | 50 | 0 | 50 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Physical Function at 3 months |
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| Physical Function at 6 months |
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| Anxiety at Baseline |
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| Anxiety at 3 months |
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| Anxiety at 6 months |
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| Depression at Baseline |
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| Depression at 3 months |
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| Depression at 6 months |
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| Fatigue at Baseline |
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| Fatigue at 3 months |
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| Fatigue at 6 months |
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| Sleep Disturbance at Baseline |
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| Sleep Disturbance at 3 months |
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| Sleep Disturbance at 6 months |
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| Satisfaction with Social Role at Baseline |
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| Satisfaction with Social Role at 3 months |
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| Satisfaction with Social Role at 6 months |
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| Pain Interference at Baseline |
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| Pain Interference at 3 months |
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| Pain Interference at 6 months |
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Linear mixed models to test difference in mean score of Fatigue PROMIS T-score from baseline to 3 months between two arms.
| The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 3 months between two arms | Linear mixed model | 0.83 | Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR). | Difference in Change | -0.94 | 2-Sided | The parameter was estimated using a difference in change in Anxiety PROMIS T-score from baseline to 3 months between two arms | Superiority | Linear mixed models to test difference in mean score of Anxiety PROMIS T-score from baseline to 3 months between two arms. |
| The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 3 months between two arms | Linear mixed model | 0.83 | Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR). | Difference in Change | -0.79 | 2-Sided | The parameter was estimated using a difference in change in Depression PROMIS T-score from baseline to 3 months between two arms | Superiority | Linear mixed models to test difference in mean score of Depression PROMIS T-score from baseline to 3 months between two arms. |
| The null hypothesis is that there is no difference in change in Pain Interference PROMIS T-score from baseline to 3 months between two arms | Linear mixed model | 0.83 | Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR). | Difference in Change | -0.78 | 2-Sided | The parameter was estimated using a difference in change in Pain Interference PROMIS T-score from baseline to 3 months between two arms | Superiority | Linear mixed models to test difference in mean score of Pain Interference PROMIS T-score from baseline to 3 months between two arms. |
| The null hypothesis is that there is no difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms | Linear mixed model | 0.98 | Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR). | Difference in Change | 0.04 | 2-Sided | The parameter was estimated using a difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms. Positive estimation parameter value indicates intervention arm better than control arm | Superiority | Linear mixed models to test difference in mean score of Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms. |
| The null hypothesis is that there is no difference in change in Physical Function PROMIS T-score from baseline to 3 months between two arms. | Linear mixed model | 0.83 | Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR). | Difference in Change | 0.55 | 2-Sided | The parameter was estimated using a difference in change in Physical Function PROMIS T-score from baseline to 3 months between two arms. Positive estimation parameter value indicates intervention arm better than control arm. | Superiority | Linear mixed models to test difference in mean score of Physical Function PROMIS T-score from baseline to 3 months between two arms. |
| The null hypothesis is that there is no difference in change in Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms. | Linear mixed model | 0.83 | Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR). | Difference in Change | 0.84 | 2-Sided | The parameter was estimated using a difference in change in Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms. Positive estimation parameter value indicates intervention arm better than control arm. | Superiority | Linear mixed models to test difference in mean score of Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms. |
| The null hypothesis is that there is no difference in change in Physical Function PROMIS T-score from baseline to 6 months between two arms. | Linear mixed model | 0.96 | Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR). | Difference in Change | -0.43 | 2-Sided | The parameter was estimated using a difference in change in Physical Function PROMIS T-score from baseline to 6 months between two arms. | Superiority | Linear mixed models to test difference in mean score of Physical Function PROMIS T-score from baseline to 6 months between two arms. |
| The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 6 months between two arms. | Linear mixed model | 0.96 | Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR). | Difference in Change | 0.07 | 2-Sided | The parameter was estimated using a difference in change in Depression PROMIS T-score from baseline to 6 months between two arms. Positive estimation parameter value indicates intervention arm better than control arm. | Superiority | Linear mixed models to test difference in mean score of Depression PROMIS T-score from baseline to 6 months between two arms. |
| The null hypothesis is that there is no difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms. | Linear mixed model | 0.96 | Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR). | Difference in Change | 0.23 | 2-Sided | Superiority | Linear mixed models to test difference in mean score of Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms. | The parameter was estimated using a difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms. Positive estimation parameter value indicates intervention arm better than control arm. |
| The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 6 months between two arms. | Linear mixed model | 0.96 | Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR). | Difference in Change | 0.77 | 2-Sided | The parameter was estimated using a difference in change in Anxiety PROMIS T-score from baseline to 6 months between two arms. Positive estimation parameter value indicates intervention arm better than control arm. | Superiority | Linear mixed models to test difference in mean score of Anxiety PROMIS T-score from baseline to 6 months between two arms. |
| The null hypothesis is that there is no difference in change in Pain Interference PROMIS T-score from baseline to 6 months between two arms. | Linear mixed model | 0.96 | Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR). | Difference in Change | 1.05 | 2-Sided | The parameter was estimated using a difference in change in Pain Interference PROMIS T-score from baseline to 6 months between two arms. Positive estimation parameter value indicates intervention arm better than control arm. | Superiority | Linear mixed models to test difference in mean score of Pain Interference PROMIS T-score from baseline to 6 months between two arms. |
| The null hypothesis is that there is no difference in change in Fatigue PROMIS T-score from baseline to 6 months between two arms. | Linear mixed model | 0.96 | Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR). | Difference in Change | 1.50 | 2-Sided | The parameter was estimated using a difference in change in Fatigue PROMIS T-score from baseline to 6 months between two arms. Positive estimation parameter value indicates intervention arm better than control arm. | Superiority | Linear mixed models to test difference in mean score of Fatigue PROMIS T-score from baseline to 6 months between two arms. |
| The null hypothesis is that there is no difference in change in Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms. | Linear mixed model | 0.64 | Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR). | Difference in Change | 2.04 | 2-Sided | The parameter was estimated using a difference in change in Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms. Positive estimation parameter value indicates intervention arm better than control arm. | Superiority | Linear mixed models to test difference in mean score of Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms. |
| Score at 3-months |
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| Score at 6-months |
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| 3-month VAS Score |
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| 6-month VAS score |
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| Frail at 3 months |
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| Frail at 6 months |
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