Dietary Adherence Enhancement in Peritoneal Dialysis

描述(申请人提供)：这项随机研究将试行一项干预措施！以自我效能理论为基础，提高对腹膜透析饮食方案的依从性。60名21岁或以上接受持续非卧床腹膜透析或夜间循环腹膜透析的人将被招募到研究中。这项研究的主要目的是：(1)描述改善饮食依从性、营养状况和参与者对其坚持饮食方案的能力的信心(自我效能)的潜在有效性；(2)确定在PD患者队列中使用带有BalanceLog软件的PDA自我监控饮食的可行性；(3)确定在研究中招募和留住PD患者队列的可行性；(4)开发和测试与自我效能、坚持障碍和社会支持有关的措施的心理测量学特性，以及(5)确定一项大型研究的样本量要求，该研究采用这种干预方法来评估饮食依从性、营养状况和自我效能的结果。参与者将被随机分为两组。A组接受为期4个月、强度随时间递减的积极干预，通过家访、诊所访问和电话随访电话进行。随后将进行为期4个月的观察和推进期，在此期间，监测参与者的进展，并在每月定期访问透析诊所期间提供额外的饮食依从性帮助。B组将接受为期4个月的注意力控制体验，在此期间，他们将接受标准饮食教育的强化，随后将接受4个月的观察期。两组的测量将作为基线，分别为4个月和8个月。

DESCRIPTION (provided by applicant): This randomized study will pilot test an intervention! based on self-efficacy theory, to improve adherence to the peritoneal dialysis dietary regimen. 60 individuals, 21 years of age or older, who are on continuous ambulatory peritoneal dialysis or nightly cycler peritoneal dialysis will be recruited to the study. The primary aims of the study are to: (1) Describe the potential effectiveness of the intervention for improving: dietary adherence, nutritional status, and participant confidence (self-efficacy) in their ability to adhere to the dietary regimen, (2) Determine the feasibility of using a PDA with BalanceLog software for self- monitoring diet in a cohort of PD patients, (3) Determine the feasibility of recruiting and retaining a cohort of PD patients in the study, (4) Develop and test the psychometric properties of measures pertaining to self-efficacy, barriers to adherence, and social support for this patient population, and (5) Determine the sample size requirements for a larger study involving this intervention approach for assessing the outcomes of dietary adherence, nutritional status, and self-efficacy. Participants will be randomized to one of 2 groups. Group A will receive a 4-month active intervention of decreasing intensity over time, delivered via home visits, clinic visits and telephone follow-up phone calls. This will be followed by a 4-month observation and booster period in which participant progress is monitored and additional assistance with dietary adherence is provided during monthly, scheduled visits to the dialysis clinic. Group B will receive a 4-month attention control experience in which they receive reinforcement of standard dietary education, followed by a 4-month observation period. Measurements will occur as baseline, 4 months, and 8 months for both groups.