Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Children and young people with chronic kidney disease (CKD) are happier at home, so when possible medical professionals teach and support parents to deliver home-based clinical care. In previous research, parents of children with CKD gave skilled care at home such as administering complex medications and injections, monitoring diet/fluids, and communicating clinical changes to medical professionals. Parents identified a need for reliable, continuously available, online materials to supplement (not replace) existing professional support and to empower them, particularly when professionals are less accessible, e.g. night-time. The aim of our study is to evaluate the impact of On-line Parent Information and Support (OPIS) use over 20 weeks on the extent to which parents perceive themselves empowered to care for their child’s CKD, and test procedures for a later national trial.

Who can participate?
Parents of children and young people up to 19 years of age with CKD whose care is managed by the multidisciplinary team (MDT) in the kidney unit in one children’s hospital in the North of England.

What does the study involve?
Participants were randomly allocated into two groups. One group (the control group) received standard support and information to support home-based clinical care-giving from the MDT. The other group (the OPIS group) received usual support plus password-protected access to OPIS for 20 weeks. Both groups completed questionnaires at the start and end of the trial to compare family condition management, whether parents felt empowered to deliver care, and the amount and helpfulness of fathers’ involvement between groups.

What are the possible benefits and risks of participating?
We anticipate that parents using OPIS will report improved empowerment. Whilst creating online resources for and with parents of children with CKD the study may also inform care/research in other conditions. By taking part in the study there are no risks of physical injury or harm. Increased levels of anxiety could result from talking about home-based care-giving but a Clinical Psychologist was available to provide support if needed. However, in previous studies parents have often described a positive therapeutic benefit of taking part in research that could improve the experience of other parents.

Where is the study run from?
The University of Manchester (UK).

When is the study starting and how long is it expected to run for?
The study started in September 2012 and ran for 12 months.

Who is funding the study?
The National Institute for Health Research, Research for Patient Benefit Programme (UK).

Who is the main contact?
Dr Veronica Swallow

Trial website

Contact information



Primary contact

Dr Veronica Swallow


Contact details

Oxford Road
M13 9PL
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The OPIS (On-line Parent Information and Support) project: meeting mothers' and fathers' information and support needs for home-based management of childhood chronic kidney disease stages 3-5



Study hypothesis

That access to OPIS plus standard support from health care professionals will improve parents' ability to manage their child's chronic kidney disease.

Ethics approval

11/N/W/0268; First MREC approval date 06/02/2012

Study design

Randomised; Interventional; Design type: Process of Care

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please contact the details below to request a participant information sheet


Topic: Children, Renal disorders; Subtopic: All Diagnoses, Renal disorders; Disease: All Diseases


Online parent information and web-based resource. The intervention group received password-protected access to OPIS as well as standard support from the MDT; the control group received standard support only

Intervention type



Not Applicable

Drug names

Primary outcome measure

Family management levels (FaMM) measured at pre- and post-20 weeks accessing the intervention

Secondary outcome measures

1. Amount and helpfulness of fathers' involvement in home-based clinical care giving (DADS)
2. Family empowerment (FES)
3. Rapid Estimate of Adult Literacy (REALM)
4. OPIS usage, acceptability and accessibility (USE)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Phase 1:
1. Children aged (0-19 years)
2. Commenced management for CKD in the preceding 5 years and require home-based care
3. (10 South Asian and 30 English)

Parents: of the above
1. New or experienced caregivers
2. Willing to participate
3. Child (if old enough) also willing to participate
4. Have existing home computer and internet access

Professionals (MDT):
1. Currently caring for one of the selected children (hospital or community)
2. Willing to participate

Phase 2:
We will establish a ‘virtual’ development group comprising four children and four young people with CKD (English and South Asian)

Parents of the above:
1. Two/three representatives of Trust-based and community health professionals
2. Two/three representatives from voluntary sector (e.g., ContactAFamily, NW Region Kidney Patients Association, HealthTalkGroup, Fatherhood Institute, Manchester South Asian Organisation)

Phase 3:
Up to 40 'new' and 'experienced' parental (biological, step or adoptive) caregivers of up to eight South Asian and 32 white children from clinical (up to 20 per group, to allow for a 25% attrition rate)

Inclusion criteria:
1. Child commenced management for CKD

Participant type


Age group




Target number of participants

Planned Sample Size: 120; UK Sample Size: 120

Participant exclusion criteria

Phase 1:
1. Do not wish to participate
2. Commenced CKD management more than 5 years ago and require home-based care

Parents of the above:
1. No home computer or internet access
2. Child not participating in study
3. Do not wish to participate

Professionals (MDT):
1. Not currently caring for one of the selected children
2. Not willing to participate

Phase 3:
1. Child no longer requires home-based care
2. Do not have home computer and internet access

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Oxford Road
M13 9PL
United Kingdom

Sponsor information


University of Manchester (UK)

Sponsor details

Oxford Road
M13 9PL
United Kingdom

Sponsor type




Funder type


Funder name

NIHR Research for Patient Benefit (RfPB) (UK); Grant Codes: PB-PG-0110-21305

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2014 results in:

Publication citations

Additional files

Editorial Notes