Pilot Feasibility Testing of a Small Randomized Controlled Trial to Evaluate a Telemedicine Stress Management and Lifestyle Group Intervention for Patients With Symptomatic Chronic Hepatitis C
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Percentage of Patients Consented Versus Approached
研究概览
简要总结
A pilot feasibility study of a small randomized controlled trial (RCT) comparing a video-conferencing cognitive behavioral coping skills (VC-CBCS) group to standard of care (SC) for symptomatic patients previously diagnosed with chronic hepatitis C to evaluate feasibility, patient satisfaction and differences in symptoms, quality of life and liver markers.
详细描述
This is a pilot feasibility study of a small randomized controlled trial (RCT) to evaluate a cognitive behavioral coping skills (CBCS) delivered via videoconferencing, referred to as the "VC-CBCS" compared to standard of care (SC). The study included a representative sample of 32 symptomatic patients who have/had chronic hepatitis C. Patients (n=32) were randomized in a 1:3 ratio to (1) standard of care (SC) or (2) to participate in 14, two hour VC-CBCS sessions. Four groups of patients were randomized and consisted of 7-9 patients each. The groups were as follows:
- Group 1: 7 patients with 5 randomized to VC-CBCS and 2 to SC;
- Group 2: 9 patients with 7 randomized to VC-CBCS and 2 to SC;
- Groups 3 and 4: 8 patients each with 6 randomized to VC-CBCS and 2 to SC each group.
Each wave of VC-CBCS patients formed a group to join the Group Facilitator via a WebEx platform on a weekly basis using iPads from their homes. The telehealth intervention provided group-based education, skills and practices involving stress management, coping with symptoms, and support for healthy lifestyle changes. The researchers examined: (1) the feasibility of delivering a group intervention via telehealth technology remotely using iPads, (2) participant satisfaction with the intervention, and (3) whether differences are observed in several outcomes between the two conditions on quality of life, physical and mental symptoms, and liver markers. Participants completed patient-reported outcome (PRO) surveys at four time points during the study, with main outcomes being change from pre-intervention to post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 and older;
- •Medically cleared by hepatology
- •Patients who are currently or were previously diagnosed with chronic Hepatitis C Viral (HCV) infection;
- •Evidence of ongoing symptoms, stress, or unhealthy lifestyle habits, defined as a score of greater than or equal to 4 on a scale 0(none) - 10 (severe) on two or more numeric rating scale questions (see Screening Form 1);
- •Able to read and speak English.
排除标准
- •Decompensated liver disease (Childs Pugh C) judged by hepatologist or recorded in patient medical record;
- •Life expectancy of <12 months estimated by hepatologist;
- •Has had a liver transplant or is on the wait list for a transplant
- •Severe alcohol or substance use disorder, psychiatric disorder or cognitive impairment that is likely to interfere with the ability to participate in telehealth groups and follow guidelines about group participation as judged by the Hepatology provider or research staff;
- •Lack of private, quiet space in home in which to participate in VC-CBCS sessions
- •Unwilling to have intervention sessions audio-recorded
结局指标
主要结局
Percentage of Patients Consented Versus Approached
时间窗: Six Months
One feasibility measure was to evaluate the percentage of patients consented compared to those approached for participation in the study.
Percentage of Standard of Care Condition Participants Retained vs Enrolled
时间窗: Six Months
Percentage of standard of care condition participants retained in the study compared to those enrolled. Retention is defined as participants who submitted PRO assessments up through T4 (end of study).
Global Health Status Mental Health Mean T-Score
时间窗: Baseline (T1), Week 14 (T4)
The PROMIS Global Health Status measure is a 10-item short form that was used to measure an individual's physical, mental, and social health. Item responses range from 5 = None to 1 = Very Severe. The adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 21.2 to 67.7. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation better (more healthy) than the general population.
Depression Mean T-score
时间窗: Baseline (T1), Week 14 (T4)
The PROMIS Depression measure is an 8-item short form that was used to measure patient-reported depression. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 41.0 to 79.4. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more (more Depression) than the general population.
Anxiety Mean T-score
时间窗: Baseline (T1), Week 14 (T4)
The PROMIS Anxiety measure is a 4-item short form that was used to measure patient-reported anxiety. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 40.3 to 81.6. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more Anxiety and T-score=40 is 1 standard deviation less Anxiety than the general population. The Anxiety T-score can range from 40.3 - 81.6.
Percentage of VC-CBCS Intervention Condition Participants Retained vs Enrolled
时间窗: Six Months
Percentage of VC-CBCS Intervention participants retained in the study compared to those enrolled. Retention is defined as participants who completed at least 3 intervention sessions.
Global Health Status Physical Health Mean T-Score
时间窗: Baseline (T1), Week 14 (T4)
The Patient Reported Outcome Measurement Information System (PROMIS) Global Health Status measure is a 10-item short form that was used to measure an individual's physical, mental, and social health. Item responses range from 5 = None to 1 = Very Severe. The adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 16.2 to 67.7. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation better (more healthy) than the general population.
Anger Mean T-score
时间窗: Baseline (T1), Week 14 (T4)
The PROMIS Anger measure is a 5-item short form that was used to measure patient-reported anger. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 32.9 to 82.9. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more Anger and T-score=40 is 1 standard deviation less Anger than the general population.
Sleep Disturbance Mean T-score
时间窗: Baseline (T1), Week 14 (T4)
The PROMIS Sleep Disturbance measure is an 8-item short form that was used to measure patient-reported sleep disturbance. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 32.0 to 73.3. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more Sleep Disturbance and T-score=40 is 1 standard deviation less Sleep Disturbance than the general population.
Percentage of Participants Consented Versus Randomized
时间窗: Six Months
One feasibility measure was to evaluate the percentage of participants randomized for the study compared to those consented.
Percentage of Surveys Completed by Participants Who Completed the Study
时间窗: Baseline (T1) to Week 14 (T4)
Percentage of surveys over time completed by participants who completed the study. Surveys included 12 patient-reported primary and secondary outcome measures. Completion was defined as submission of each of the 12 surveys at Time 1 (T1) through Time 4 (T4).
Fatigue Mean T-score
时间窗: Baseline (T1), Week 14 (T4)
The PROMIS Fatigue measure is a 7-item short form that was used to measure patient-reported fatigue. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 29.4 to 83.2. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more Fatigue and T-score=40 is 1 standard deviation less Fatigue than the general population.
Pain Interference Mean T-score
时间窗: Baseline (T1), Week 14 (T4)
The PROMIS Pain Interference measure is an 8-item short form that was used to measure patient-reported pain interference. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 41.6 to 75.6. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more Pain Interference and T-score=40 is 1 standard deviation less Pain Interference than the general population.
次要结局
- Percentage of Participants Who Improved Vegetable Consumption by One or More Categories(Baseline (T1) to Week 14 (T4))
- Mean Number of Minutes of Moderate Activity Per Week(Baseline (T1) , Week 14 (T4))
- Percentage of Participants Who Complete Vigorous Activity for at Least 10 Minutes at a Time(Baseline (T1), Week 14 (T4))
- Mean Number of Minutes of Vigorous Activity Per Week(Baseline (T1), Week 14 (T4))
- Percentage of Overall Medication Adherence(Baseline (T1), Week 14 (T4))
- Percentage of Participants Who Complete Moderate Activity for at Least 10 Minutes at a Time(Baseline (T1), Week 14 (T4))
- Coping Skills Confidence Mean Score(Baseline (T1), Week 14 (T4))
- Aspartate Aminotransferase (AST) Mean Score for Females(Baseline (T1), Week 14 (T4))
- Pittsburgh Sleep Quality Index (PSQI) Sleep Quality Mean Score(Baseline (T1), Week 14 (T4))
- Perceived Stress Mean Score(Baseline (T1), Week 14 (T4))
- Percentage of Participants Who Reduced Regular Soda Intake by One or More Categories(Baseline (T1) to Week 14 (T4))
- Change in Body Mass Index (BMI)(Baseline (T1) to Week 14 (T4))
- Participant Satisfaction With VC-CBCS Intervention Mean Score(Baseline (T1) to Week 14 (T4))
- Aspartate Aminotransferase (AST) Mean Score for Males(Baseline (T1), Week 14 (T4))
- Alanine Aminotransferase (ALT) Mean Score for Females(Baseline (T1), Week 14 (T4))
- Alanine Aminotransferase (ALT) Mean Score for Males(Baseline (T1), Week 14 (T4))
- Percentage of Participants Who Improved Fruit Consumption by One or More Categories(Baseline (T1) to Week 14 (T4))
- Mean Time Spent Sitting on the Weekdays(Baseline (T1), Week 14 (T4))
- Percentage of Participants Who Reduced Meals From Fast Food Restaurants by One or More Categories(Baseline (T1) to Week 14 (T4))
- Healthy Sleep Behaviors Mean Score(Baseline (T1), Week 14 (T4))
- Alcohol Total Mean Score(Baseline (T1), Week 14 (T4))
- Percentage of Participants Who Increased Dinners Prepared at Home by 1 or More Days(Baseline (T1) to Week 14 (T4))
- Change in Weight (Lbs)(Baseline (T1) to Week 14 (T4))
- Change in Percent Weight Change(Baseline (T1) to Week 14 (T4))
- Prescription Drug Misuse Total Mean Score(Baseline (T1), Week 14 (T4))
- Mean Time Spent Sitting on the Weekends(Baseline (T1), Week 14 (T4))
- Percentage of Participants Who Reduced Diet Soda Intake by One or More Categories(Baseline (T1) to Week 14 (T4))
- Non-prescription Street Drug Use Total Mean Score(Baseline (T1), Week 14 (T4))
- Pittsburgh Sleep Quality Index (PSQI) Sleep Efficiency Composite Mean Score(Baseline (T1), Week 14 (T4))
- Percentage of Participants Who Reduced Fruit Juice Intake by One or More Categories(Baseline (T1) to Week 14 (T4))