Behavioral Management of Phosphorus in Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of Hemodialysis (HD) patients that are eligible for the study
研究概览
简要总结
The purpose of this randomized clinical trial is to evaluate alternative technology-supported behavioral approaches to engaging 42 maintenance hemodialysis (HD) patients with persistent hyperphosphatemia in phosphorus binder adherence and dietary phosphorus restriction. Participants will be randomized to 1 of 3 intervention groups: (1) Education (Edu); (2) Edu + Self-Monitoring (SM); or (3) Edu + SM + Social Cognitive Theory (SCT)-based training program.
详细描述
Investigators will evaluate the intervention in terms of feasibility and acceptability, behavior change at 12 and 24 weeks (reported phosphorus binder adherence, reported nutrient intakes, normalized protein catabolic rate), and clinical outcomes (serum phosphorus concentrations, symptoms). In addition, the impact of the different behavioral approaches on self-efficacy at 12 and 24 weeks, and the mediating effects of self-efficacy in facilitating behavioral changes and clinical outcomes will be examined.
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
- 19 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving thrice-weekly hemodialysis treatment for at least 3 months
- •3-month average serum phosphorus concentration >5.5 mg/dL
排除标准
- •Unable to participate meaningfully in the combined Edu + SM + SCT intervention, including:
- •Unable to read and/or speak English
- •Self-monitoring application is currently available in English only (patients will not be excluded from participation on the basis of race/ethnicity)
- •Cognitively-impaired
- •Physically-impaired
- •Institutionalized or otherwise having limited control over diet
- •Life expectancy of <1 year per dialysis center staff
- •Women who are pregnant or become pregnant during the study
研究组 & 干预措施
Edu + SM + Social Cognitive Theory (SCT)
干预措施: Education (Edu) (Behavioral)
Edu + SM + Social Cognitive Theory (SCT)
干预措施: SM intervention (Behavioral)
Edu + SM + Social Cognitive Theory (SCT)
干预措施: Social Cognitive Therapy (SCT) (Behavioral)
Education (Edu)
干预措施: Education (Edu) (Behavioral)
Edu + Self-Monitoring (SM)
干预措施: Education (Edu) (Behavioral)
Edu + Self-Monitoring (SM)
干预措施: SM intervention (Behavioral)
结局指标
主要结局
Proportion of Hemodialysis (HD) patients that are eligible for the study
时间窗: 24 Weeks
Measure of feasibility
Proportion of enrolled participants who complete the study
时间窗: 24 Weeks
Measure of Acceptability
Proportion of eligible patients who agree to participate
时间窗: 24 Weeks
Measure of feasibility
次要结局
- Balance Wise Self-Efficacy for Restricting Dietary Sodium in Hemodialysis Scale(24 Weeks)
- Normalized protein catabolic rate (nPCR)(24 Weeks)
- Serum phosphorus.(24 Weeks)
- Frequency and severity of participant symptoms assessed via an investigator-developed questionnaire(24 Weeks)
- 8-item Morisky Medication Adherence Survey (MMAS-8)(24 Weeks)
- Reported dietary energy, protein and phosphorus intake(2 Weeks)