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. 2019 Aug 6;2019(8):CD012379. doi: 10.1002/14651858.CD012379.pub2

Welch 2013.

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 type classification: self‐monitoring

  • eHealth intervention used: PDA application


Intervention group
  • Dietary Intake Monitoring Application (DIMA)

    • Electronic dietary self‐monitoring app

    • Participants trained for 2‐3 hours; used for 1 week to familiarise

    • Participants can scan food labels, feedback screen in relation to dietary prescriptions to facilitate awareness of performance attainment, totals automatically computed

    • Dietary and usage data downloaded at each dialysis session

    • 24‐hour telephone number provided


Control group
  • Daily Activity Monitoring Application (DAMA)

    • DAMA to ensure these participants got equal time as to DIMA

    • Participants used DAMA for 1 week to familiarise; trained for 30 min

    • Instructed to self‐monitor activity in 8 categories (walking, biking, weight lifting, shopping, yard work, childcare, housework, cooking)

    • Selected icons representing activities and amount of time. Could view total daily activity time.

    • Usage data downloaded every dialysis session

    • 24 hour telephone number provided

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