The Online Parent Information and Support project
| ISRCTN | ISRCTN84283190 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84283190 |
| Secondary identifying numbers | 11186 |
- Submission date
- 25/07/2014
- Registration date
- 25/07/2014
- Last edited
- 17/12/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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 childs 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 childrens 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
veronica.swallow@manchester.ac.uk
Contact information
Scientific
Oxford Road
Manchester
M13 9PL
United Kingdom
| veronica.swallow@manchester.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Process of Care |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact the details below to request a participant information sheet |
| 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 acronym | OPIS |
| 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(s) | 11/N/W/0268; First MREC approval date 06/02/2012 |
| Condition | Topic: Children, Renal disorders; Subtopic: All Diagnoses, Renal disorders; Disease: All Diseases |
| Intervention | 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 | Other |
| 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 study start date | 08/12/2011 |
| Overall study end date | 27/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 0 Years |
| Upper age limit | 19 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 120; UK Sample Size: 120 |
| 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 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 | 08/12/2011 |
| Recruitment end date | 27/03/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
M13 9PL
United Kingdom
Sponsor information
University/education
Oxford Road
Manchester
M13 9PL
England
United Kingdom
"ROR" |
https://ror.org/027m9bs27 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/12/2014 | Yes | No |
