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

Poorgholami 2016a.

Methods
  • Study design: parallel RCT; 75 assessed for eligibility, 75 randomised

  • Study duration: 2 months

  • Study follow‐up: 2 months

Participants
  • Country: Iran

  • Setting: community, dialysis centre

  • Receiving maintenance HD patients

  • Number: intervention group 1 (25); intervention group 2 (25); control group (25)

  • Mean age ± SD (years): intervention group 1 (50.92 ± 6.46); intervention group 2 (47.84 ± 8.65); control group (49.4 ± 6.04)

  • Sex (M): intervention group 1 (44%); intervention group 2 (60%); control group (60%)

  • Exclusion criteria: history of serious or adverse experiences in the last six months; treatment with antidepressant medications; hospitalisation due to acute disease; and unwillingness to participate or to continue with the study

Interventions
  • Intervention type classification: behavioural counselling

  • eHealth intervention used: Telehealth


Intervention groups
  • Intervention group 1: self‐care education

    • 5 consecutive one hour instructions about the disease process and symptoms as well as importance of HD, diet, fluid restriction, daily body weight control, physical activity, smoking cessation, stress management, muscular relaxation, and monitoring the vital signs

    • Given a copy of an instruction booklet comprising a summary of material taught in the 5 instructional sessions

  • Intervention group 2: self‐care education plus telephone support

    • 5 consecutive one hour instructions about the disease process and symptoms as well as importance of haemodialysis, diet, fluid restriction, daily body weight control, physical activity, smoking cessation, stress management, muscular relaxation, and monitoring the vital signs

    • Given a copy of an instruction booklet comprising a summary of material taught in the 5 instructional sessions.

    • 3 telephone calls per week for the next two months following the instructions. The duration of each call was 20 minutes, which could also vary according to the patients’ needs. The content of telephone conversations included issues, which had been taught in the five instructional sessions and had been mentioned in the booklet as well as answers to the patients’ questions. In addition, the patients were told that they could call the investigator any time for their ad hoc questions.


Control group
  • Routine care offered in the hospital

Outcomes
  • Miller’s questionnaire of hope (Conducted on day 56 after the study)

Notes
  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Block randomisation
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 Blinding of participants High risk Not possible due to nature of the intervention
Blinding of participants and personnel (performance bias) 
 Blinding of personnel High risk Follow‐up calls made by investigator or his assistant, likely blinding was not upheld
Blinding of outcome assessment (detection bias) 
 Objective outcome Low risk No objective outcomes were measured
Blinding of outcome assessment (detection bias) 
 Subjective outcomes Unclear risk Completed in the dialysis ward, no mention of who gave out to patients. Valid questionnaire
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All participants included in analysis
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias Unclear risk Insufficient information to permit judgement