Methods |
Study design: parallel RCT; 89 assessed for eligibility, 44 randomised
Study duration: 6‐week intervention
Study follow‐up: 8 week follow‐up
|
Participants |
Country: USA
Setting: community, dialysis unit
Patients receiving maintenance HD
Number (randomised/analysed): intervention group (24/16); control group (20/17)
Mean age ± SD (years): intervention group (53 ± 15.1); control group (47.1 ± 11.5)
Sex (M/F): intervention group (12/12); control group (13/7)
Exclusion criteria: living in an assisted or extended care facility, receiving outpatient HD on a temporary basis following a PD complication or an episode of transplant rejection, reported having no intent to comply with dietary or fluid restrictions and were receiving home HD.
|
Interventions |
Intervention group
Control group
|
Outcomes |
Average IDWG (baseline and 6 weeks)
Cardiac Diet Self‐Efficacy Instrument and Fluid Self‐Efficacy Scale (baseline, 6 weeks, 14 weeks) ‐ RAs read out questionnaires to patients
Benefits of Sodium Adherence and Fluid Adherence Scale (baseline, 6 weeks, 14 weeks) ‐ RAs read out questionnaires to patients
7‐item mastery scale (baseline, 6 weeks, 14 weeks) ‐ RAs read out questionnaires to patients
Dietary intake in intervention only (Week 1, week 6) ‐ Automatically computed dietary intake data based on patient recorded food items from DIMA. Summed weekly intake and then divided by number of days for which entries made
Acceptability (end of study)
|
Notes |
Dietary intake data was only recorded and reported for the intervention group
Funding source: supported by grants from NIH/National Institute of Biomedical Imaging and Bioengineering (R21EB007083), a T32 Postdoctoral Training Grant (NIH T32 NR007066), and Indiana University School of Nursing Research Investment Funds
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Randomisation was blocked and stratified by dialysis unit |
Allocation concealment (selection bias) |
Unclear risk |
Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias)
Blinding of participants |
High risk |
Blinding not possible |
Blinding of participants and personnel (performance bias)
Blinding of personnel |
High risk |
No mention of blinding but likely would be broken |
Blinding of outcome assessment (detection bias)
Objective outcome |
Low risk |
Objective measures (IDWG) used |
Blinding of outcome assessment (detection bias)
Subjective outcomes |
High risk |
Participant data were collected by RAs during HD treatment. The RAs read questionnaire items for baseline and follow‐up data collections to each participant, who responded verbally to each item |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
overall attrition rate of 25% by the end of the 8‐week follow‐up. There were no statistically significant differences in age, gender, race, dialysis unit, or group between those who continued in the study and those who did not |
Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to permit judgement |
Other bias |
High risk |
Under powered, small sample size only 2 dialysis units involved and not generalisable |