AIDS (Acquired Immunodeficiency Syndrome), HIV (Human Immunodeficiency Virus)
Conditions
Keywords
HIV/AIDS Health Management App, HIV/AIDS symptoms
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALVIP app without HIV-related symptom strategies.
The control group will receive the VIP app without HIV-related symptom strategies
BEHAVIORALVIP app that delivers HIV-related symptom strategies.
The Intervention group will receive the VIP app that delivers HIV-related symptom strategies
Sponsors
National Institute of Nursing Research (NINR)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. HIV+ 2. Age 18 or over 3. Able to read and respond in English 4. Reside within the US 5. Willing to participate in an online survey.
Exclusion criteria
1. HIV-negative 2. under age 18 3. Unwilling to provide key data (i.e., age, information about symptoms) on the online survey.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Burden Score | 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) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Baseline, 3 months, and 6 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Score on SF-12 | 3 months and 6 months | 12-Item Medical Outcomes Study Short Form (SF-12) is a health survey to measure health-related quality of life. |
| Score on Engagement With Health Care Provider Scale | 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. |
| Score of the VAS | Baseline, 3 months, and 6 months | 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. |
| Score on Fried's Frailty Phenotype | Baseline, 3 months, and 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| 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 | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 3 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 44 Participants | 89 Participants |
| Age, Continuous | 51.87 years STANDARD_DEVIATION 10.41 | 53.66 years STANDARD_DEVIATION 11.21 | 52.77 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 20 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 30 Participants | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants | 31 Participants | 66 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 12 Participants | 20 Participants |
| Race (NIH/OMB) White | 5 Participants | 5 Participants | 10 Participants |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 17 Participants | 27 Participants | 44 Participants |
| Sex: Female, Male Male | 33 Participants | 23 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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).
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Symptom Burden Score | Decreased sex drive - period 2 | 0.85 score on a scale | Standard Deviation 1.42 |
| Intervention | Symptom Burden Score | Anxiety - period 1 | 1.08 score on a scale | Standard Deviation 1.47 |
| Intervention | Symptom Burden Score | Anxiety - period 2 | 0.83 score on a scale | Standard Deviation 1.36 |
| Intervention | Symptom Burden Score | Anxiety - period 3 | 0.80 score on a scale | Standard Deviation 1.34 |
| Intervention | Symptom Burden Score | Changes in appetite - period 1 | 0.85 score on a scale | Standard Deviation 1.36 |
| Intervention | Symptom Burden Score | Changes in appetite - period 2 | 0.79 score on a scale | Standard Deviation 1.34 |
| Intervention | Symptom Burden Score | Changes in appetite - period 3 | 0.76 score on a scale | Standard Deviation 1.36 |
| Intervention | Symptom Burden Score | Clumsiness or difficulty with balance - period 1 | 0.88 score on a scale | Standard Deviation 1.49 |
| Intervention | Symptom Burden Score | Clumsiness or difficulty with balance - period 2 | 0.83 score on a scale | Standard Deviation 1.41 |
| Intervention | Symptom Burden Score | Clumsiness or difficulty with balance - period 3 | 0.94 score on a scale | Standard Deviation 1.49 |
| Intervention | Symptom Burden Score | Difficulty concentrating - period 1 | 0.76 score on a scale | Standard Deviation 1.32 |
| Intervention | Symptom Burden Score | Difficulty concentrating - period 2 | 0.68 score on a scale | Standard Deviation 1.29 |
| Intervention | Symptom Burden Score | Difficulty concentrating - period 3 | 0.70 score on a scale | Standard Deviation 1.31 |
| Intervention | Symptom Burden Score | Constipation, gas, or bloating - period 1 | 1.28 score on a scale | Standard Deviation 1.53 |
| Intervention | Symptom Burden Score | Constipation, gas, or bloating - period 2 | 1.16 score on a scale | Standard Deviation 1.57 |
| Intervention | Symptom Burden Score | Constipation, gas, or bloating - period 3 | 1.12 score on a scale | Standard Deviation 1.53 |
| Intervention | Symptom Burden Score | Cough - period 1 | 0.77 score on a scale | Standard Deviation 1.35 |
| Intervention | Symptom Burden Score | Cough - period 2 | 0.72 score on a scale | Standard Deviation 1.32 |
| Intervention | Symptom Burden Score | Cough - period 3 | 0.76 score on a scale | Standard Deviation 1.32 |
| Intervention | Symptom Burden Score | Depression - period 1 | 1.36 score on a scale | Standard Deviation 1.48 |
| Intervention | Symptom Burden Score | Depression - period 2 | 1.33 score on a scale | Standard Deviation 1.58 |
| Intervention | Symptom Burden Score | Depression - period 3 | 1.32 score on a scale | Standard Deviation 1.56 |
| Intervention | Symptom Burden Score | Decreased sex drive - period 1 | 0.98 score on a scale | Standard Deviation 1.49 |
| Intervention | Symptom Burden Score | Decreased sex drive - period 3 | 0.85 score on a scale | Standard Deviation 1.41 |
| Intervention | Symptom Burden Score | Diarrhea- period 1 | 0.81 score on a scale | Standard Deviation 1.36 |
| Intervention | Symptom Burden Score | Diarrhea - period 2 | 0.63 score on a scale | Standard Deviation 1.29 |
| Intervention | Symptom Burden Score | Diarrhea - period 3 | 0.62 score on a scale | Standard Deviation 1.28 |
| Intervention | Symptom Burden Score | Difficulty remembering - period 1 | 1.01 score on a scale | Standard Deviation 1.45 |
| Intervention | Symptom Burden Score | Difficulty remembering - period 2 | 0.92 score on a scale | Standard Deviation 1.4 |
| Intervention | Symptom Burden Score | Difficulty remembering - period 3 | 0.83 score on a scale | Standard Deviation 1.36 |
| Intervention | Symptom Burden Score | Lightheadedness or dizziness - period 1 | 0.83 score on a scale | Standard Deviation 1.39 |
| Intervention | Symptom Burden Score | Difficulty falling asleep - period 3 | 1.47 score on a scale | Standard Deviation 1.74 |
| Intervention | Symptom Burden Score | Fatigue - period 1 | 1.83 score on a scale | Standard Deviation 1.53 |
| Intervention | Symptom Burden Score | Fatigue - period 2 | 1.41 score on a scale | Standard Deviation 1.6 |
| Intervention | Symptom Burden Score | Fatigue - period 3 | 1.31 score on a scale | Standard Deviation 1.53 |
| Intervention | Symptom Burden Score | Fever, night sweats, or chills - period 1 | 0.72 score on a scale | Standard Deviation 1.27 |
| Intervention | Symptom Burden Score | Fever, night sweats, or chills - period 2 | 0.65 score on a scale | Standard Deviation 1.28 |
| Intervention | Symptom Burden Score | Fever, night sweats, or chills - period 3 | 0.70 score on a scale | Standard Deviation 1.3 |
| Intervention | Symptom Burden Score | Heartburn - period 1 | 0.96 score on a scale | Standard Deviation 1.42 |
| Intervention | Symptom Burden Score | Heartburn - period 2 | 0.79 score on a scale | Standard Deviation 1.34 |
| Intervention | Symptom Burden Score | Heartburn - period 3 | 0.84 score on a scale | Standard Deviation 1.43 |
| Intervention | Symptom Burden Score | Problems achieving an erection - period 1 | 0.72 score on a scale | Standard Deviation 1.37 |
| Intervention | Symptom Burden Score | Problems achieving an erection - period 2 | 0.59 score on a scale | Standard Deviation 1.25 |
| Intervention | Symptom Burden Score | Problems achieving an erection - period 3 | 0.62 score on a scale | Standard Deviation 1.3 |
| Intervention | Symptom Burden Score | Muscle aches or pain - period 1 | 2.17 score on a scale | Standard Deviation 1.54 |
| Intervention | Symptom Burden Score | Muscle aches or pain - period 2 | 1.86 score on a scale | Standard Deviation 1.59 |
| Intervention | Symptom Burden Score | Muscle aches or pain - period 3 | 1.78 score on a scale | Standard Deviation 1.66 |
| Intervention | Symptom Burden Score | Neuropathy - period 1 | 1.94 score on a scale | Standard Deviation 1.65 |
| Intervention | Symptom Burden Score | Neuropathy - period 2 | 1.77 score on a scale | Standard Deviation 1.68 |
| Intervention | Symptom Burden Score | Neuropathy - period 3 | 1.86 score on a scale | Standard Deviation 1.64 |
| Intervention | Symptom Burden Score | Pain or discomfort during sex - period 1 | 0.27 score on a scale | Standard Deviation 0.87 |
| Intervention | Symptom Burden Score | Pain or discomfort during sex - period 2 | 0.36 score on a scale | Standard Deviation 1.06 |
| Intervention | Symptom Burden Score | Pain or discomfort during sex - period 3 | 0.38 score on a scale | Standard Deviation 1.04 |
| Intervention | Symptom Burden Score | Ringing in ears or noise intolerance - period 1 | 0.73 score on a scale | Standard Deviation 1.34 |
| Intervention | Symptom Burden Score | Ringing in ears or noise intolerance - period 2 | 0.58 score on a scale | Standard Deviation 1.12 |
| Intervention | Symptom Burden Score | Ringing in ears or noise intolerance - period 3 | 0.61 score on a scale | Standard Deviation 1.3 |
| Intervention | Symptom Burden Score | Shortness of breath - period 1 | 0.86 score on a scale | Standard Deviation 1.37 |
| Intervention | Symptom Burden Score | Shortness of breath - period 2 | 1.00 score on a scale | Standard Deviation 1.48 |
| Intervention | Symptom Burden Score | Shortness of breath - period 3 | 0.73 score on a scale | Standard Deviation 1.29 |
| Intervention | Symptom Burden Score | Speech difficulties - period 1 | 0.27 score on a scale | Standard Deviation 0.87 |
| Intervention | Symptom Burden Score | Speech difficulties - period 2 | 0.34 score on a scale | Standard Deviation 0.95 |
| Intervention | Symptom Burden Score | Speech difficulties - period 3 | 0.42 score on a scale | Standard Deviation 1.06 |
| Intervention | Symptom Burden Score | Difficulty staying asleep - period 1 | 1.44 score on a scale | Standard Deviation 1.61 |
| Intervention | Symptom Burden Score | Difficulty staying asleep - period 2 | 1.49 score on a scale | Standard Deviation 1.73 |
| Intervention | Symptom Burden Score | Difficulty staying asleep - period 3 | 1.53 score on a scale | Standard Deviation 1.69 |
| Intervention | Symptom Burden Score | Difficulty with urination - period 1 | 0.45 score on a scale | Standard Deviation 1.09 |
| Intervention | Symptom Burden Score | Difficulty with urination - period 2 | 0.55 score on a scale | Standard Deviation 1.19 |
| Intervention | Symptom Burden Score | Difficulty with urination - period 3 | 0.48 score on a scale | Standard Deviation 1.05 |
| Intervention | Symptom Burden Score | Nausea or vomiting - period 1 | 0.56 score on a scale | Standard Deviation 1.16 |
| Intervention | Symptom Burden Score | Nausea or vomiting - period 2 | 0.46 score on a scale | Standard Deviation 1.08 |
| Intervention | Symptom Burden Score | Nausea or vomiting - period 3 | 0.41 score on a scale | Standard Deviation 1.02 |
| Intervention | Symptom Burden Score | Unplanned changes in weight - period 1 | 0.71 score on a scale | Standard Deviation 1.39 |
| Intervention | Symptom Burden Score | Unplanned changes in weight - period 2 | 0.41 score on a scale | Standard Deviation 1.02 |
| Intervention | Symptom Burden Score | Unplanned changes in weight - period 3 | 0.73 score on a scale | Standard Deviation 1.38 |
| Intervention | Symptom Burden Score | Lightheadedness or dizziness - period 2 | 0.76 score on a scale | Standard Deviation 1.35 |
| Intervention | Symptom Burden Score | Lightheadedness or dizziness - period 3 | 0.82 score on a scale | Standard Deviation 1.43 |
| Intervention | Symptom Burden Score | Dry eyes - period 1 | 0.78 score on a scale | Standard Deviation 1.3 |
| Intervention | Symptom Burden Score | Dry eyes - period 2 | 0.63 score on a scale | Standard Deviation 1.22 |
| Intervention | Symptom Burden Score | Dry eyes - period 3 | 0.53 score on a scale | Standard Deviation 1.15 |
| Intervention | Symptom Burden Score | Thirst or dry mouth - period 1 | 1.35 score on a scale | Standard Deviation 1.53 |
| Intervention | Symptom Burden Score | Thirst or dry mouth - period 2 | 0.98 score on a scale | Standard Deviation 1.41 |
| Intervention | Symptom Burden Score | Thirst or dry mouth - period 3 | 0.97 score on a scale | Standard Deviation 1.4 |
| Intervention | Symptom Burden Score | Difficulty falling asleep - period 1 | 1.41 score on a scale | Standard Deviation 1.63 |
| Intervention | Symptom Burden Score | Difficulty falling asleep - period 2 | 1.27 score on a scale | Standard Deviation 1.68 |
| Control | Symptom Burden Score | Unplanned changes in weight - period 3 | 0.57 score on a scale | Standard Deviation 1.22 |
| Control | Symptom Burden Score | Problems achieving an erection - period 2 | 0.24 score on a scale | Standard Deviation 0.88 |
| Control | Symptom Burden Score | Anxiety - period 1 | 1.06 score on a scale | Standard Deviation 1.49 |
| Control | Symptom Burden Score | Difficulty staying asleep - period 2 | 1.19 score on a scale | Standard Deviation 1.61 |
| Control | Symptom Burden Score | Anxiety - period 2 | 0.71 score on a scale | Standard Deviation 1.37 |
| Control | Symptom Burden Score | Problems achieving an erection - period 3 | 0.23 score on a scale | Standard Deviation 0.87 |
| Control | Symptom Burden Score | Anxiety - period 3 | 0.78 score on a scale | Standard Deviation 1.38 |
| Control | Symptom Burden Score | Lightheadedness or dizziness - period 1 | 0.66 score on a scale | Standard Deviation 1.22 |
| Control | Symptom Burden Score | Changes in appetite - period 1 | 0.70 score on a scale | Standard Deviation 1.19 |
| Control | Symptom Burden Score | Muscle aches or pain - period 1 | 2.12 score on a scale | Standard Deviation 1.59 |
| Control | Symptom Burden Score | Changes in appetite - period 2 | 0.67 score on a scale | Standard Deviation 1.21 |
| Control | Symptom Burden Score | Difficulty staying asleep - period 3 | 1.22 score on a scale | Standard Deviation 1.64 |
| Control | Symptom Burden Score | Changes in appetite - period 3 | 0.55 score on a scale | Standard Deviation 1.15 |
| Control | Symptom Burden Score | Muscle aches or pain - period 2 | 1.74 score on a scale | Standard Deviation 1.62 |
| Control | Symptom Burden Score | Clumsiness or difficulty with balance - period 1 | 0.82 score on a scale | Standard Deviation 1.39 |
| Control | Symptom Burden Score | Dry eyes - period 3 | 0.57 score on a scale | Standard Deviation 1.06 |
| Control | Symptom Burden Score | Clumsiness or difficulty with balance - period 2 | 0.66 score on a scale | Standard Deviation 1.28 |
| Control | Symptom Burden Score | Muscle aches or pain - period 3 | 1.79 score on a scale | Standard Deviation 1.59 |
| Control | Symptom Burden Score | Clumsiness or difficulty with balance - period 3 | 0.58 score on a scale | Standard Deviation 1.25 |
| Control | Symptom Burden Score | Difficulty with urination - period 1 | 0.32 score on a scale | Standard Deviation 0.96 |
| Control | Symptom Burden Score | Difficulty concentrating - period 1 | 1.14 score on a scale | Standard Deviation 1.5 |
| Control | Symptom Burden Score | Neuropathy - period 1 | 1.67 score on a scale | Standard Deviation 1.63 |
| Control | Symptom Burden Score | Difficulty concentrating - period 2 | 0.82 score on a scale | Standard Deviation 1.37 |
| Control | Symptom Burden Score | Lightheadedness or dizziness - period 2 | 0.45 score on a scale | Standard Deviation 1.07 |
| Control | Symptom Burden Score | Difficulty concentrating - period 3 | 0.83 score on a scale | Standard Deviation 1.39 |
| Control | Symptom Burden Score | Neuropathy - period 2 | 1.66 score on a scale | Standard Deviation 1.63 |
| Control | Symptom Burden Score | Constipation, gas, or bloating - period 1 | 1.21 score on a scale | Standard Deviation 1.47 |
| Control | Symptom Burden Score | Difficulty with urination - period 2 | 0.28 score on a scale | Standard Deviation 0.89 |
| Control | Symptom Burden Score | Constipation, gas, or bloating - period 2 | 1.11 score on a scale | Standard Deviation 1.51 |
| Control | Symptom Burden Score | Neuropathy - period 3 | 1.56 score on a scale | Standard Deviation 1.63 |
| Control | Symptom Burden Score | Constipation, gas, or bloating - period 3 | 0.93 score on a scale | Standard Deviation 1.46 |
| Control | Symptom Burden Score | Difficulty falling asleep - period 1 | 1.52 score on a scale | Standard Deviation 1.69 |
| Control | Symptom Burden Score | Cough - period 1 | 0.90 score on a scale | Standard Deviation 1.36 |
| Control | Symptom Burden Score | Pain or discomfort during sex - period 1 | 0.21 score on a scale | Standard Deviation 0.76 |
| Control | Symptom Burden Score | Cough - period 2 | 0.76 score on a scale | Standard Deviation 1.32 |
| Control | Symptom Burden Score | Difficulty with urination - period 3 | 0.30 score on a scale | Standard Deviation 0.91 |
| Control | Symptom Burden Score | Cough - period 3 | 0.74 score on a scale | Standard Deviation 1.29 |
| Control | Symptom Burden Score | Pain or discomfort during sex - period 2 | 0.18 score on a scale | Standard Deviation 0.74 |
| Control | Symptom Burden Score | Depression - period 1 | 1.36 score on a scale | Standard Deviation 1.62 |
| Control | Symptom Burden Score | Lightheadedness or dizziness - period 3 | 0.32 score on a scale | Standard Deviation 0.91 |
| Control | Symptom Burden Score | Depression - period 2 | 1.00 score on a scale | Standard Deviation 1.51 |
| Control | Symptom Burden Score | Pain or discomfort during sex - period 3 | 0.12 score on a scale | Standard Deviation 0.6 |
| Control | Symptom Burden Score | Depression - period 3 | 0.91 score on a scale | Standard Deviation 1.46 |
| Control | Symptom Burden Score | Nausea or vomiting - period 1 | 0.27 score on a scale | Standard Deviation 0.8 |
| Control | Symptom Burden Score | Decreased sex drive - period 1 | 1.09 score on a scale | Standard Deviation 1.49 |
| Control | Symptom Burden Score | Decreased sex drive - period 2 | 0.68 score on a scale | Standard Deviation 1.32 |
| Control | Symptom Burden Score | Ringing in ears or noise intolerance - period 1 | 0.61 score on a scale | Standard Deviation 1.26 |
| Control | Symptom Burden Score | Decreased sex drive - period 3 | 0.58 score on a scale | Standard Deviation 1.28 |
| Control | Symptom Burden Score | Thirst or dry mouth - period 1 | 1.13 score on a scale | Standard Deviation 1.41 |
| Control | Symptom Burden Score | Diarrhea- period 1 | 0.62 score on a scale | Standard Deviation 1.19 |
| Control | Symptom Burden Score | Ringing in ears or noise intolerance - period 2 | 0.67 score on a scale | Standard Deviation 1.31 |
| Control | Symptom Burden Score | Diarrhea - period 2 | 0.52 score on a scale | Standard Deviation 1.18 |
| Control | Symptom Burden Score | Nausea or vomiting - period 2 | 0.34 score on a scale | Standard Deviation 0.95 |
| Control | Symptom Burden Score | Diarrhea - period 3 | 0.37 score on a scale | Standard Deviation 0.99 |
| Control | Symptom Burden Score | Ringing in ears or noise intolerance - period 3 | 0.60 score on a scale | Standard Deviation 1.19 |
| Control | Symptom Burden Score | Difficulty remembering - period 1 | 1.15 score on a scale | Standard Deviation 1.53 |
| Control | Symptom Burden Score | Dry eyes - period 1 | 0.63 score on a scale | Standard Deviation 1.17 |
| Control | Symptom Burden Score | Difficulty remembering - period 2 | 1.08 score on a scale | Standard Deviation 1.51 |
| Control | Symptom Burden Score | Shortness of breath - period 1 | 0.94 score on a scale | Standard Deviation 1.41 |
| Control | Symptom Burden Score | Difficulty remembering - period 3 | 0.97 score on a scale | Standard Deviation 1.44 |
| Control | Symptom Burden Score | Nausea or vomiting - period 3 | 0.19 score on a scale | Standard Deviation 0.69 |
| Control | Symptom Burden Score | Difficulty falling asleep - period 2 | 1.21 score on a scale | Standard Deviation 1.66 |
| Control | Symptom Burden Score | Shortness of breath - period 2 | 0.81 score on a scale | Standard Deviation 1.39 |
| Control | Symptom Burden Score | Difficulty falling asleep - period 3 | 1.28 score on a scale | Standard Deviation 1.68 |
| Control | Symptom Burden Score | Thirst or dry mouth - period 3 | 0.97 score on a scale | Standard Deviation 1.39 |
| Control | Symptom Burden Score | Fatigue - period 1 | 1.73 score on a scale | Standard Deviation 1.52 |
| Control | Symptom Burden Score | Shortness of breath - period 3 | 0.72 score on a scale | Standard Deviation 1.3 |
| Control | Symptom Burden Score | Fatigue - period 2 | 1.32 score on a scale | Standard Deviation 1.51 |
| Control | Symptom Burden Score | Unplanned changes in weight - period 1 | 0.90 score on a scale | Standard Deviation 1.52 |
| Control | Symptom Burden Score | Fatigue - period 3 | 1.07 score on a scale | Standard Deviation 1.4 |
| Control | Symptom Burden Score | Speech difficulties - period 1 | 0.34 score on a scale | Standard Deviation 0.97 |
| Control | Symptom Burden Score | Fever, night sweats, or chills - period 1 | 0.77 score on a scale | Standard Deviation 1.4 |
| Control | Symptom Burden Score | Dry eyes - period 2 | 0.64 score on a scale | Standard Deviation 1.18 |
| Control | Symptom Burden Score | Fever, night sweats, or chills - period 2 | 0.63 score on a scale | Standard Deviation 1.28 |
| Control | Symptom Burden Score | Speech difficulties - period 2 | 0.25 score on a scale | Standard Deviation 0.82 |
| Control | Symptom Burden Score | Fever, night sweats, or chills - period 3 | 0.60 score on a scale | Standard Deviation 1.22 |
| Control | Symptom Burden Score | Unplanned changes in weight - period 2 | 0.19 score on a scale | Standard Deviation 0.69 |
| Control | Symptom Burden Score | Heartburn - period 1 | 0.81 score on a scale | Standard Deviation 1.44 |
| Control | Symptom Burden Score | Speech difficulties - period 3 | 0.21 score on a scale | Standard Deviation 0.73 |
| Control | Symptom Burden Score | Heartburn - period 2 | 0.70 score on a scale | Standard Deviation 1.4 |
| Control | Symptom Burden Score | Thirst or dry mouth - period 2 | 0.96 score on a scale | Standard Deviation 1.4 |
| Control | Symptom Burden Score | Heartburn - period 3 | 0.55 score on a scale | Standard Deviation 1.27 |
| Control | Symptom Burden Score | Difficulty staying asleep - period 1 | 1.48 score on a scale | Standard Deviation 1.66 |
| Control | Symptom Burden Score | Problems achieving an erection - period 1 | 0.23 score on a scale | Standard Deviation 0.83 |
Comparison: The null hypothesis is that there is no difference in change in mean clumsy score from period 1 to period 2 between the two armsp-value: 0.83Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean neuropathy score from period 1 to period 2 between the two armsp-value: 0.02Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean problems maintaining an erection score from period 1 to period 2 between the two armsp-value: 0.11Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean dry mouth score from period 1 to period 2 between the two armsp-value: 0.02Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean ringing in ear score from period 1 to period 2 between the two armsp-value: 0.01Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean vomit score from period 1 to period 2 between the two armsp-value: 0.01Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean dry eyes score from period 1 to period 2 between the two armsp-value: 0.02Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean heartburn score from period 1 to period 2 between the two armsp-value: 0.11Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean diarrhea score from period 1 to period 2 between the two armsp-value: 0.21Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean constipation score from period 1 to period 2 between the two armsp-value: 0.33Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean appetite change score from period 1 to period 2 between the two armsp-value: 0.46Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean difficulty remembering score from period 1 to period 2 between the two armsp-value: 0.46Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean fatigue score from period 1 to period 2 between the two armsp-value: 0.58Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean cough score from period 1 to period 2 between the two armsp-value: 0.92Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean urination score from period 1 to period 2 between the two armsp-value: 0.84Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean fever score from period 1 to period 2 between the two armsp-value: 0.72Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean pain during sex score from period 1 to period 2 between the two armsp-value: 0.48Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean dizziness score from period 1 to period 2 between the two armsp-value: 0.54Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean muscle aches score from period 1 to period 2 between the two armsp-value: 0.56Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean speech difficulties score from period 1 to period 2 between the two armsp-value: 0.22Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean decreased sex drive score from period 1 to period 2 between the two armsp-value: 0.4Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean anxiety score from period 1 to period 2 between the two armsp-value: 0.35Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean difficulty concentrating score from period 1 to period 2 between the two armsp-value: 0.11Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean shortness of breath score from period 1 to period 2 between the two armsp-value: 0.11Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean difficulty falling asleep score from period 1 to period 2 between the two armsp-value: 0.15Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean unplanned changes in weight score from period 1 to period 2 between the two armsp-value: 0.08Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean depression score from period 1 to period 2 between the two armsp-value: 0.02Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean difficulty staying asleep score from period 1 to period 2 between the two armsp-value: 0.01Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean dry mouth score from period 1 to period 3 between the two armsp-value: 0.08Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean ringing in ear score from period 1 to period 3 between the two armsp-value: 0.08Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean dry eyes score from period 1 to period 3 between the two armsp-value: 0.08Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean maintaining an erection score from period 1 to period 3 between the two armsp-value: 0.71Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean vomit score from period 1 to period 3 between the two armsp-value: 0.41Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean neuropathy score from period 1 to period 3 between the two armsp-value: 0.84Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean urination score from period 1 to period 3 between the two armsp-value: 0.71Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean appetite change score from period 1 to period 3 between the two armsp-value: 0.88Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean shortness of breath score from period 1 to period 3 between the two armsp-value: 0.93Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean difficulty remembering score from period 1 to period 3 between the two armsp-value: 0.93Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean difficulty concentrating score from period 1 to period 3 between the two armsp-value: 0.12Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean muscle aches score from period 1 to period 3 between the two armsp-value: 0.94Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean diarrhea score from period 1 to period 3 between the two armsp-value: 0.97Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean fatigue score from period 1 to period 3 between the two armsp-value: 0.95Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean anxiety score from period 1 to period 3 between the two armsp-value: 0.95Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean decreased sex drive score from period 1 to period 3 between the two armsp-value: 0.1Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean constipation score from period 1 to period 3 between the two armsp-value: 0.93Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean fever score from period 1 to period 3 between the two armsp-value: 0.84Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean cough score from period 1 to period 3 between the two armsp-value: 0.84Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean heartburn score from period 1 to period 3 between the two armsp-value: 0.54Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean pain during sex score from period 1 to period 3 between the two armsp-value: 0.13Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean clumsy score from period 1 to period 3 between the two armsp-value: 0.18Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean difficulty falling asleep score from period 1 to period 3 between the two armsp-value: 0.29Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean speech difficulties score from period 1 to period 3 between the two armsp-value: 0.01Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean unplanned changes in weight score from period 1 to period 3 between the two armsp-value: 0.08Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean dizziness score from period 1 to period 3 between the two armsp-value: 0.08Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean difficulty staying asleep score from period 1 to period 3 between the two armsp-value: 0.09Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in mean depression score from period 1 to period 3 between the two armsp-value: 0.05Linear mixed model
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.
Time frame: Baseline, 3 months, and 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Anxiety at 6 months | 44.35 T-Score | Standard Deviation 9.29 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Physical Function at Baseline | 43.79 T-Score | Standard Deviation 9.28 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Physical Function at 3 months | 45.37 T-Score | Standard Deviation 9.09 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Physical Function at 6 months | 44.35 T-Score | Standard Deviation 9.29 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Anxiety at Baseline | 56.28 T-Score | Standard Deviation 9.45 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Anxiety at 3 months | 54.88 T-Score | Standard Deviation 8.29 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Depression at Baseline | 53.58 T-Score | Standard Deviation 8.56 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Depression at 3 months | 52.12 T-Score | Standard Deviation 8.64 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Depression at 6 months | 52.62 T-Score | Standard Deviation 7.89 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Fatigue at Baseline | 53.81 T-Score | Standard Deviation 9.4 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Fatigue at 3 months | 51.75 T-Score | Standard Deviation 9.93 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Fatigue at 6 months | 54.23 T-Score | Standard Deviation 9.28 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Sleep Disturbance at Baseline | 54.98 T-Score | Standard Deviation 8.79 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Sleep Disturbance at 3 months | 52.69 T-Score | Standard Deviation 8.95 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Sleep Disturbance at 6 months | 52.54 T-Score | Standard Deviation 8.28 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Satisfaction with Social Role at Baseline | 47.31 T-Score | Standard Deviation 9.97 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Satisfaction with Social Role at 3 months | 48.00 T-Score | Standard Deviation 9.88 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Satisfaction with Social Role at 6 months | 48.47 T-Score | Standard Deviation 8.47 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Pain Interference at Baseline | 59.12 T-Score | Standard Deviation 7.7 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Pain Interference at 3 months | 56.56 T-Score | Standard Deviation 10.73 |
| Intervention | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Pain Interference at 6 months | 57.43 T-Score | Standard Deviation 9.53 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Fatigue at 3 months | 52.63 T-Score | Standard Deviation 10.21 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Pain Interference at Baseline | 59.56 T-Score | Standard Deviation 8.59 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Physical Function at Baseline | 41.43 T-Score | Standard Deviation 8.18 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Fatigue at 6 months | 51.46 T-Score | Standard Deviation 8.45 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Physical Function at 3 months | 41.98 T-Score | Standard Deviation 8.46 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Satisfaction with Social Role at 3 months | 45.99 T-Score | Standard Deviation 9.52 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Sleep Disturbance at Baseline | 54.66 T-Score | Standard Deviation 8.63 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Anxiety at Baseline | 55.56 T-Score | Standard Deviation 9.67 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Pain Interference at 6 months | 56.94 T-Score | Standard Deviation 7.28 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Anxiety at 3 months | 55.03 T-Score | Standard Deviation 9.02 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Physical Function at 6 months | 41.63 T-Score | Standard Deviation 7.43 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Anxiety at 6 months | 53.32 T-Score | Standard Deviation 9.46 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Sleep Disturbance at 3 months | 51.52 T-Score | Standard Deviation 9.58 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Depression at Baseline | 53.32 T-Score | Standard Deviation 10.11 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Satisfaction with Social Role at 6 months | 46.15 T-Score | Standard Deviation 8.1 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Depression at 3 months | 52.52 T-Score | Standard Deviation 10.02 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Sleep Disturbance at 6 months | 50.29 T-Score | Standard Deviation 9.3 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Depression at 6 months | 52.34 T-Score | Standard Deviation 8.54 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Pain Interference at 3 months | 57.52 T-Score | Standard Deviation 9.45 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Fatigue at Baseline | 52.99 T-Score | Standard Deviation 9 |
| Control | Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 | Satisfaction with Social Role at Baseline | 45.05 T-Score | Standard Deviation 8.64 |
Comparison: The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 6 months between two arms.p-value: 0.96Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in Fatigue PROMIS T-score from baseline to 3 months between two armsp-value: 0.83Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 3 months between two armsp-value: 0.83Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 3 months between two armsp-value: 0.83Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in Pain Interference PROMIS T-score from baseline to 3 months between two armsp-value: 0.83Linear mixed model
Comparison: 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 armsp-value: 0.98Linear mixed model
Comparison: 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.p-value: 0.83Linear mixed model
Comparison: 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.p-value: 0.83Linear mixed model
Comparison: 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.p-value: 0.96Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 6 months between two arms.p-value: 0.96Linear mixed model
Comparison: 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.p-value: 0.96Linear mixed model
Comparison: 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.p-value: 0.96Linear mixed model
Comparison: The null hypothesis is that there is no difference in change in Fatigue PROMIS T-score from baseline to 6 months between two arms.p-value: 0.96Linear mixed model
Comparison: 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.p-value: 0.64Linear mixed model
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.
Time frame: 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.
Time frame: Baseline, 3 months, and 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Score of the VAS | Baseline VAS Score | 88.49 percentage of medication | Standard Deviation 17.34 |
| Intervention | Score of the VAS | 3-month VAS Score | 86.89 percentage of medication | Standard Deviation 24.43 |
| Intervention | Score of the VAS | 6-month VAS score | 86.88 percentage of medication | Standard Deviation 21.49 |
| Control | Score of the VAS | Baseline VAS Score | 83.91 percentage of medication | Standard Deviation 26.45 |
| Control | Score of the VAS | 3-month VAS Score | 87.30 percentage of medication | Standard Deviation 20.99 |
| Control | Score of the VAS | 6-month VAS score | 88.63 percentage of medication | Standard Deviation 20.45 |
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.
Time frame: Baseline, 3 months, and 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Score on Engagement With Health Care Provider Scale | Score at Baseline | 17.78 score on a scale | Standard Deviation 8.07 |
| Intervention | Score on Engagement With Health Care Provider Scale | Score at 3-months | 20.17 score on a scale | Standard Deviation 8.68 |
| Intervention | Score on Engagement With Health Care Provider Scale | Score at 6-months | 18.05 score on a scale | Standard Deviation 7.72 |
| Control | Score on Engagement With Health Care Provider Scale | Score at Baseline | 17.13 score on a scale | Standard Deviation 6.52 |
| Control | Score on Engagement With Health Care Provider Scale | Score at 3-months | 17.33 score on a scale | Standard Deviation 5.43 |
| Control | Score on Engagement With Health Care Provider Scale | Score at 6-months | 18.70 score on a scale | Standard Deviation 8.02 |
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.
Time frame: Baseline, 3 months, and 6 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Score on Fried's Frailty Phenotype | Frail at Baseline | 25 Participants |
| Intervention | Score on Fried's Frailty Phenotype | Frail at 3 months | 19 Participants |
| Intervention | Score on Fried's Frailty Phenotype | Frail at 6 months | 17 Participants |
| Control | Score on Fried's Frailty Phenotype | Frail at Baseline | 26 Participants |
| Control | Score on Fried's Frailty Phenotype | Frail at 3 months | 21 Participants |
| Control | Score on Fried's Frailty Phenotype | Frail at 6 months | 17 Participants |