Feasibility and Acceptability of Physical Activity Monitoring as an Educational Tool in the Management of Paediatric Type 1 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 1
- Sponsor
- Sheffield Hallam University
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Recruitment
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Physical activity (PA) can have positive health outcomes for children with type 1 diabetes (T1DM), yet being physically active can have unwanted side effects due to fluctuations in blood glucose (BG) level. Children and parents need support to help understand the relationship between PA and BG level, and how to use PA as a vehicle to better manage the condition. Using PA monitoring could help HCPs raise awareness about PA, discuss PA and facilitate diabetes management. This research will explore the feasibility and acceptability of PA monitoring as a clinical tool to help the management of paediatric T1DM.
Detailed Description
Physical activity (PA) can have positive health outcomes for children with type 1 diabetes (T1DM) such as improved diabetes control, lipid profile and body composition, yet activity levels are low. The unpredictable nature of children's everyday activity causes fluctuations in blood glucose (BG) level. Low and high BG level are side-effects of PA, have significant symptoms and can cause a range of chronic complications. Parents typically have responsibility for diabetes management in preadolescent children and perceive PA as a challenge due to constant concerns about BG levels (Quirk et al., 2015). Children and parents need support to help understand the relationship between PA and BG control and how to use PA as a vehicle through which to better manage the condition. T1DM healthcare professionals (HCPs) perceive a lack of i) competence, ii) confidence and iii) time to provide PA advice and education in the clinical setting. HCPs perceive a need for evidence-based resources to facilitate PA discussion, education and promotion (Quirk et al., 2015). Physical activity monitoring is already a widely recognised and accepted tool, with potential utility in paediatric diabetes. One such approach could be that HCPs graphically convey children's PA levels and use this to raise awareness and promote discussion about daily PA level. In those using constant glucose monitoring devices, daily BG values could be graphically documented to help explain the relationship between PA and BG level. These devices have shown acceptability among children with T1DM. However, whether they can facilitate PA discussion and education is unknown. This research will explore parents, children and HCPs' perceptions of PA monitoring in clinical practice. A PA monitoring programme will be developed, implemented in a small cohort of children with T1DM and evaluated for feasibility and acceptability. In the future, 'physical activity clinical champions' could be trained to use activity monitoring for PA education and promotion in clinic settings.
Investigators
Helen Quirk
Principal Investigator
Sheffield Hallam University
Eligibility Criteria
Inclusion Criteria
- •Arm 1 Children with type 1 diabetes Aged 7-11 years (age range may be increased to 6-12 years if recruitment is problematic) Diagnosed with type 1 diabetes for at least 12 months Consenting primary caregiver Willingness of child and parent for the child to wear activity monitor
- •Arm 2 Children with type 1 diabetes using a personal CGM OR CGM on loan from clinic as part of clinical care Aged 7-11 years (age range may be increased to 6-12 years if recruitment is problematic) Diagnosed with type 1 diabetes for at least 12 months Consenting primary caregiver Willingness of child and parent for the child to wear an activity monitor
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Recruitment
Time Frame: During recruitment (0 months)
Recruitment will be recorded during the recruitment period as the number of eligible participants that consented to participate. The following data will be assessed: number meeting eligibility criteria, reasons for ineligibility, number consenting and reasons for non-participation; demographic profile of participating and nonparticipating (e.g., to assess inclusion of ethnic minority and hard-to-reach groups), and withdrawals (with reasons where available).
Retention
Time Frame: At follow-up (~3 months)
Retention rate will be defined as the number of participants completing the intervention, including all follow-up data collection (follow-up and interview) compared to the number started. Retention will be recorded by the researcher at follow-up and interview.
Acceptability
Time Frame: At follow-up (~3 months)
User acceptability of research and intervention processes will be assessed by interview with children and parents. Interviews will explore acceptability of i) recruitment, ii) outcome measures, iii) participant burden, iv) the activity monitor and v) feedback sessions to determine appropriateness of the intervention for use in a future trial and clinical practice. Interviews will explore perceptions of change. Interviews will be conducted by a member of the research team who is experienced in qualitative research and who, ideally, has had no direct involvement with the intervention implementation.
Data completion
Time Frame: At baseline (0 months) and follow-up (~3 months)
Data completion rate is determined by recording the proportion of participants who complete the outcome measures at baseline and follow-up. To assess data completion, completion of questionnaire measures will be recorded at baseline and follow-up (complete and partial or non-completion with reasons, time to complete). The feasibility of gathering routinely collected data available in patients' clinic notes at baseline and follow-up will be assessed. Feasibility of collecting observational data in this way will be determined if \>85% of our sample have complete clinical records available. Data completion will be recorded by the researcher at baseline and follow-up.
Adherence
Time Frame: At follow-up (~3 months)
Adherence will refer to the proportion of participants who adhere to the activity monitoring protocol (meet the valid wear-time protocol) and proportion of participants who attend all scheduled activity monitoring sessions with the researcher. Adherence will be monitored by the researcher at baseline, follow-up and throughout the intervention.
Occurrence of adverse events
Time Frame: At baseline (0 months), during intervention (0-3 months) and at follow-up (~3 months)
ccurrence of adverse events related to the intervention (e.g., severe hypoglycaemia, accident or injury) will be assessed by reviewing patient notes and patient self-report.
Secondary Outcomes
- Parental self-efficacy for diabetes management(At baseline (0 months) and follow-up (~3 months))
- Demographics(At baseline (0 months))
- Parental fear of hypoglycaemia(At baseline (0 months) and follow-up (~3 months))
- Clinical information(At baseline (0 months) and follow-up (~3 months))