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Interventions to support Patient Activation for adults on hemoDialysis (IPAD Study)

The IPAD study: tailored educational and self-management Intervention to support Patient Activation in adults on hemoDialysis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000504112
Acronym
IPAD Study
Enrollment
24
Registered
2019-03-28
Start date
2018-03-01
Completion date
2020-03-30
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project aims to evaluate the impact of an intervention designed to improve activation on patient outcomes and investigate whether activation levels of patients on haemodialysis change overtime. This study will involve adult participants 18 years and over who are new to haemodialysis and commence at Monash Medical Centre. It will be a single centre, prospective participant blinded randomised controlled trial with 18 months follow up. Participants will be randomly distributed into a control and an intervention group.

Interventions

Provide essential routine information on haemodialysis mechanism, symptom control, medication management, nutrition advice, fluid restriction, and coping methods; standard pamphlets and electronic resources Materials: Pamphlets from Kidney Health Australia and from resources provided by Monash Health, namely: Fluid Facts (Amgen) Low Phosphate (Amgen) Low Potassium - Fruit (Amgen) Low Potassium - Vegetable (Amgen) Calcium and phosphate balance with kidney disease fact sheet [Kidney Health Austra

Provide essential routine information on haemodialysis mechanism, symptom control, medication management, nutrition advice, fluid restriction, and coping methods; standard pamphlets and electronic resources Materials: Pamphlets from Kidney Health Australia and from resources provided by Monash Health, namely: Fluid Facts (Amgen) Low Phosphate (Amgen) Low Potassium - Fruit (Amgen) Low Potassium - Vegetable (Amgen) Calcium and phosphate balance with kidney disease fact sheet [Kidney Health Australia (KHA)] Drink water instead (KHA) Salt and your kidneys fact sheet (KHA) Hyperphosphataemia (Shire) One-on-one individual self-management training session conducted by trained nephrology nurses. The duration of the session depends on the participant's activation level; one hour for participants with low activation level and 30 minutes for highly activated participants. Content includes; 1) introduction to the self-management concept 2) addressing the importance and benefits of self-management 3) forming an action plan based on the self-management theory, introducing a log book to record blood pressure, fluid intake, daily weight, medications and diet. Follow-up phone calls with receptive interview techniques which encourage patient-initiated talk to address current concerns, goal settings, behavioural modifications, services utilizations Interventions delivered by the researchers - dialysis nurses involved in the study Delivery: face-to-face (initial session) followed by telephone interviews as remaining contacts Number of times: as per protocol, minimum weekly for 4 weeks, gradually decreasing to fortnightly for 2 fortnights, then 1 month after that for 6 months for participants with lower activation levels. Interventions stop on the month following the fortnightly follow up for participants with high activation levels. Duration: 25 weeks for low activation participants; 9 weeks for high activation participants Interventions will be personalised to each individual in the intervention arm. This will occur by practicing motivational interview techniques to probe areas of concern from the participants, and in turn the interventions to be addressed on that particular follow up will be based on the participants' perceived problem list. Intervention adherence not assessed. Effectiveness will be assessed by post-intervention PAM score at the end of the treatment period, which will be 18 months after enrolment to the study. Location: Monash Medical Centre - Clayton VIC Australia 3168

Sponsors

Denise Fraginal
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Recent commencement of haemodialysis (within 3 months) haemodialysis at Monash Medical Centre (MMC) and being 18 years of age or over

Exclusion criteria

Cognitive impairment Inability to speak fluently in English language Diagnosis of acute kidney injury Participants opting to go to private haemodialysis satellite units permanently Being an established patient on haemodialysis (having been on hemodialysis for more than 3 months)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026