Adaptation and Pilot Testing a Behavioral Physical Activity Intervention With Peer Support for Women With HIV and Co-Occurring Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Participant attrition
研究概览
简要总结
This clinical trial will assess the acceptability and feasibility of a peer-supported behavioral physical activity intervention for women living with HIV and Hypertension.
详细描述
An individually randomized pilot trial (N=50) of an adapted behavioral physical activity (PA) intervention will be used to assess the feasibility and acceptability of providing exercise prescription, peer support, and home blood pressure monitoring to women ages 40+ living with HIV and Hypertension. Secondary outcomes to be assessed include systolic and diastolic blood pressure, PA time and intensity, PA self-efficacy, perceived social support, and health-related quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •woman living with HIV
- •age 40 and above
- •diagnosed with HTN
- •access to a personal phone for study-related phone calls
- •willing to wear an accelerometer on their waist or hip for 7 days at beginning and end of 12-week intervention
- •able to ambulate independently
- •English speaking
排除标准
- •unable to provide informed consent due to cognitive deficit, serious mental illness, or active substance use
研究组 & 干预措施
Peer support arm
Women in the peer support arm will receive weekly peer contacts via phone or text message to assess progress towards study-assigned physical activity goal/prescription and to provide motivational counseling and support.
干预措施: Blood pressure self monitoring (Behavioral)
Control arm
Women in the control arm will receive physical activity prescription and home blood pressure monitoring, but will not receive peer support calls.
干预措施: Exercise Prescription (Behavioral)
Control arm
Women in the control arm will receive physical activity prescription and home blood pressure monitoring, but will not receive peer support calls.
干预措施: Blood pressure self monitoring (Behavioral)
Peer support arm
Women in the peer support arm will receive weekly peer contacts via phone or text message to assess progress towards study-assigned physical activity goal/prescription and to provide motivational counseling and support.
干预措施: Peer support (Behavioral)
Peer support arm
Women in the peer support arm will receive weekly peer contacts via phone or text message to assess progress towards study-assigned physical activity goal/prescription and to provide motivational counseling and support.
干预措施: Exercise Prescription (Behavioral)
结局指标
主要结局
Participant attrition
时间窗: From enrollment to end of 12 week intervention
Measure of participants who withdraw from the behavioral trial in the intervention and the control groups to determine feasibility of enrolling and retaining individuals in the trial. Approximately 15% attrition is expected in a behavioral clinical trial. Higher levels of attrition relate to lower feasibility.
Intervention acceptability: Satisfaction
时间窗: Mid-point (6-week) assessment and end of intervention assessment (12-week)
Participant satisfaction with the intervention: Treatment Satisfaction Questionnaire adapted for behavioral treatment. The measure includes 11 items asked on a Likert-type scale from 1=Extremely Dissatisfied to 7=Extremely Satisfied, with 3 items asked on a 1-5 scale. 1 item will be removed that asks about medication side effects. Scores can range from 10 to 64. Higher scores mean higher satisfaction with the treatment/intervention.
Intervention Acceptability: Treatment burden
时间窗: At 6-week (mid-point intervention) and 12-weeks (end of intervention)
The Brief Patient Experiences with Treatment and Self Management will be used. The scale includes 32 items total. Most items use a 5-point Likert-type scale from 1=very easy to 5=very difficult. Some items use a 5-point Likert scale (agreement). And some use a Likert-type frequency/intensity measure from 1=not at all to 5=very much. Does not apply=0. Total scores range from 0 to 150. Higher scores mean higher treatment burden.
次要结局
- Systolic and diastolic blood pressure(Measured at baseline, 6-weeks (mid-point) and 12-weeks (end of intervention))
- Daily physical activity: Accelerometer measured(Collected at baseline pre-randomization, and at 12-weeks (end of intervention))
- Self reported physical activity(Collected at baseline, 6 weeks (mid-point), and 12-weeks (post-intervention))
- Physical Activity Self Efficacy(Collected at baseline, 6-weeks (mid-point) and 12-weeks (post-intervention))
- Physical activity enjoyment(Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention))
- Social support for physical activity(Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention))
研究者
Kaylee Crockett
Assistant Professor
University of Alabama at Birmingham