A novel interactive health communication application (IHCA) for parents of children with chronic/long-term conditions: Feasibility and trends in change on outcomes of a small-scale randomized controlled trial

Background: Families living with long-term conditions such as Chronic Kidney Disease (CKD) stages 3-5 face multiple challenges and respond to these challenges in various ways; some adapt well while others struggle, and family response to a condition is closely related to the child’s outcomes. We developed with families and professionals a novel, condition-specific Interactive Health Communication Application, the online parent information and support (OPIS) program to promote parents’ management ability. OPIS comprises a comprehensive mix of clinical care-giving and psychosocial information and support. Objectives: The purpose of this paper is to (1) assess feasibility of a future full-scale randomized controlled trial (RCT) of OPIS in terms of recruitment and retention, data collection procedures, and psychometric performance of the study measures in the target population; and (2) investigate trends in change in outcome measures in a small-scale RCT in parents of children with CKD stages 3-5 Methods: Parents were recruited from a pediatric nephrology clinic and randomly assigned to one of two treatment groups: usual support for home-based clinical caregiving (control) or usual support plus password-protected access to OPIS for 20 weeks (intervention). Both groups completed study measures at study entry and exit. We assessed feasibility descriptively in terms of recruitment and retention rates overall; assessed recruitment, retention, and uptake of the intervention between groups; and compared family condition management, empowerment to deliver care and fathers’ involvement between groups Results: 55 parents of 39 children (42% of eligible families) were recruited. Of those 19/26 (73%) of OPIS parents and 22/29 (76%) of control group parents were retained through completion of 20 week data collection. The overall retention rate was 41/55 (75%). The 41 parents completing the trial were asked to respond to the same 10 questionnaire scales at both baseline and 20 weeks later; 10 scores were missing at baseline and nine were missing at 20 weeks. Site user statistics provided evidence that all intervention group parents accessed OPIS. Analysis found that intervention group parents showed a greater improvement in perceived competence to manage their child’s condition compared to control group parents (adjusted mean Family Management Measure [FaMM] Condition Management Ability Scale intervention group 44.5 v control group 41.9, difference = 2.6, 95% CI -1.6 to 6.7). Differences between the groups in the FaMM Family Life Difficulty Scale (39.9 v 36.3, difference = 3.7, 95% CI -4.9 to 12.2) appeared to agree with a qualitative observation that OPIS helped parents maintain an awareness of the impact of their child’s condition. Conclusion: A full-scale RCT of the effectiveness of OPIS is feasible. OPIS has the potential to beneficially affect self-reported outcomes, including parents’ perceived competence to manage home-based clinical care for children with CKD stage 3-5. Our design and methodology can be transferred to the management of other childhood conditions. Trial registration: ISRCTN84283190 http://www.controlled-trials.com/ISRCTN84283190