Dietary Adherence Enhancement in Peritoneal Dialysis

描述（由申请人提供）：本随机研究将对干预措施进行初步测试！基于自我效能理论，提高腹膜透析饮食方案的依从性。本研究将招募60名接受持续性非卧床腹膜透析或夜间腹膜透析的21岁或以上的个体。研究的主要目的是：（1）描述干预措施在改善以下方面的潜在有效性：饮食依从性、营养状况和参与者信心（2）确定使用具有BalanceLog软件的PDA用于PD患者队列中的自我监测饮食的可行性，（3）确定在研究中招募和保留一组PD患者的可行性，（4）开发和测试与该患者群体的自我效能、依从性障碍和社会支持有关的测量的心理测量特性，以及（5）确定一项更大规模研究的样本量要求，该研究涉及这种干预方法，用于评估饮食依从性、营养状况和自我效能的结果。受试者将被随机分配至2组之一。A组将接受4个月的主动干预，强度随时间推移而降低，通过家庭访视、诊所访视和电话随访进行。随后是4个月的观察和加强期，在此期间监测受试者的进展，并在每月定期访视透析诊所期间提供饮食依从性的额外帮助。B组将接受为期4个月的注意力控制体验，其中他们接受标准饮食教育的强化，随后是为期4个月的观察期。两组的测量将在基线、4个月和8个月时进行。

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.