Palliative care in chronic kidney disease study (PACKS study)

Not Applicable

Completed

• Conditions: Advanced chronic kidney disease; Urological and Genital Diseases; Chronic kidney disease, stage 5

• Registration Number: ISRCTN06857980
• Lead Sponsor: Queen's University of Belfast (UK)

Brief Summary

2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26163382 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28417662 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29767579

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-01
• Study Completion: 2016-12-09
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

Patients:
1. Stage 5 chronic kidney disease with estimated glomerular filtration rate = 20 mL/minute as measured by the Modification of Diet in Renal Disease (MDRD) formula (Levey et al 1999)
2. A confirmed decision for conservative management, i.e. management without dialysis or other renal replacement therapy. The decision for conservative kidney management will be confirmed with the nephrologist responsible for each patient.
3. Aged over 18 years

Carers:
1. Primary carer for patient with stage 5 chronic kidney disease who has made a confirmed decision for conservative kidney management as agreed with clinicians
2. Aged over 18 years
3. Patient has agreed that the carer can be approached to participate
4. The carer has contacted staff and ‘opted in’ to the study (added 04/02/2015)

Renal physicians/CNS:
1. Experience of managing clinical consultations of patients with stage 5 chronic kidney disease who opt for conservative kidney management
2. Employed in the renal specialty

Exclusion Criteria

Patients:
1. Patients lacking capacity to give consent to participate. Capacity for consent to participate will be assessed in collaboration with the clinicians.
2. Stage 1-4 chronic kidney disease
3. Hasn't made a confirmed decision for conservative management
4. Under the age of 18
5. Non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available

Carers:
1. Carers who lack capacity to give consent to participate in the study
2. Under the age of 18
3. Patient has not agreed that the carer can be approached to participate
4. Non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available
5. Carer has not contacted staff and ‘opted in’ to the study (added 04/02/2015)

Renal physicians/CNS:
1. No experience of managing clinical consultations of patients who opt for conservative kidney management
2. Not employed in the renal specialty

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measures as of 04/02/2015:<br> Quality of life (QOL) of patients at 3 months measured using the EQ-VAS.<br><br> Previous primary outcome measures:<br> Quality of life (QOL) of patients at 3 months measured using the EQ-5D-5L visual analogue scale.<br>