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An Intervention to Reduce Hypoglycemia Fear in Parents of Young Kids with Type 1 Diabetes Through Video-Based Telemedicine (REDCHiP): Trial Design, Feasibility, and Acceptability.

ABSTRACT: Background: Fear of hypoglycemia (FH) is common in parents of young children with type 1 diabetes (T1D) and problematically linked to maladaptive behaviors to avoid low blood glucose, parenting stress, and burnout. This study examined the feasibility and acceptability of a novel group-based telemedicine intervention to reduce FH in parents of young children with T1D. Materials and Methods: Forty-three families of a young child with T1D (1-6 years of age; diagnosed with T1D for at least 6 months) enrolled in the study and 36 completed the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) intervention. We assessed intervention feasibility with rates of attrition, intervention attendance, and fidelity to the treatment manual. We assessed acceptability with treatment satisfaction surveys and qualitative interviews (from a subset of completers; n?=?10) about intervention acceptability, facilitators, and challenges. Results: Study attrition was 21%, including long-term follow-up (16% before or during the treatment phase). On average, parents attended 94% of intervention sessions and fidelity to the treatment manual was 89%. Intervention completers reported high satisfaction with the treatment groups (89% average satisfaction rating). Parent-reported positive influencers of the REDCHiP intervention were increased knowledge, fear awareness, coping strategies, confidence, behavioral parenting strategies, and support, whereas intervention challenges included feeling fearful or overwhelmed, family stress, lack of trust, and difficulty connecting with other group members. Conclusions: The REDCHiP intervention demonstrated initial feasibility and acceptability. Next steps include determining the intervention's impact on objective parent and child outcomes (e.g., glycemic control, parental FH, and parental stress/distress) as well as large-scale efficacy testing.

SUBMITTER: Marker AM

PROVIDER: S-EPMC6945796 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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An Intervention to Reduce Hypoglycemia Fear in Parents of Young Kids with Type 1 Diabetes Through Video-Based Telemedicine (REDCHiP): Trial Design, Feasibility, and Acceptability.

Marker Arwen M AM Monzon Alexandra D AD Nelson Eve-Lynn EL Clements Mark A MA Patton Susana R SR

Diabetes technology & therapeutics 20191113 1

Background: Fear of hypoglycemia (FH) is common in parents of young children with type 1 diabetes (T1D) and problematically linked to maladaptive behaviors to avoid low blood glucose, parenting stress, and burnout. This study examined the feasibility and acceptability of a novel group-based telemedicine intervention to reduce FH in parents of young children with T1D. Materials and Methods: Forty-three families of a young child with T1D (1-6 years of age; diagnosed wit ...[more]

PMID: 31517512

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Project description:BackgroundThe feasibility of telemedicine in diagnosing and treating nonacute headaches, such as primary headaches (migraine and tension-type) and medication-overuse headaches has not been previously investigated. By eliminating the need of travel to specialists, telemedicine may offer significant time and money savings.ObjectivesOur objective was to estimate the acceptance of telemedicine and investigate the feasibility and cost savings of telemedicine consultations in diagnosing and treating nonacute headaches.MethodsFrom September 2012 to March 2015, nonacute headache patients from Northern Norway who were referred to neurologists through an electronic application system were consecutively screened and randomized to participate in either telemedicine or traditional specialist visits. All patients were consulted by two neurologists at the neurological department in Tromsø University Hospital. Feasibility outcomes were compared between telemedicine and traditional groups. Baseline characteristics and costs were then compared between rural and urban patients. Travel costs were calculated by using the probabilistic method of the Norwegian traveling agency: the cheapest means of public transport for each study participant. Loss of pay was calculated based on the Norwegian full-time employee's average salary: < 3.5 hours=a half day's salary, > 3.5 hours spent on travel and consultation=one day's salary. Distance and time spent on travel were estimated by using Google Maps.ResultsOf 557 headache patients screened, 479 were found eligible and 402 accepted telemedicine participation (83.9%, 402/479) and were included in the final analyses. Of these, 202 received traditional specialist consultations and 200 received telemedicine. All patients in the telemedicine group were satisfied with the video quality, and 198 (99%, 198/200) were satisfied with the sound quality. The baseline characteristics as well as headache diagnostics and follow-up appointments, and the investigation, advice, and prescription practices were not statistically different between the two randomized groups. In addition, telemedicine consultations were shorter than traditional visits (38.8 vs 43.7 min, P<.001). The travel cost per rural individual (292/402, 73%) was €249, and estimated lost income was €234 per visit. The travel cost in the urban area (110/402, 27%) was €6, and estimated lost income was €117 per visit. The median traveling distance for rural patients was 526 km (range 1892 km), and the median traveling time was 7.8 hours (range 27.3 hours). Rural patients had a longer waiting time than urban patients (64 vs 47 days, P=.001), and fewer women were referred from rural areas (P=.04). Rural women reported higher pain scores than urban women (P=.005).ConclusionOur study shows that telemedicine is an accepted, feasible, time-saving, and cost-saving alternative to traditional specialist consultations for nonacute headaches.Trial registrationClinicaltrials.gov NCT02270177; http://clinicaltrials.gov/ct2/show/NCT02270177 (Archived by WebCite at http://www.webcitation.org/6hmoHGo9Q).

Project description:BackgroundMany patients who have been treated for breast cancer experience high levels of fear that the cancer will return. The FORECAST pilot study showed that for a third of the patients, fears of cancer recurrence (FCR) increase during radiotherapy treatment and that conversations with their therapeutic radiographer at the weekly review meetings might help patients manage these concerns. This study aims to develop a communication skills training package (KEW, for 'Know', 'Encourage' and 'Warm-up') for therapeutic radiographers based on the findings of the FORECAST pilot study and on active input from patients and radiographers. This package will be piloted in a single centre to evaluate its acceptability and to prepare for a multi-centre clinical trial.MethodsThe study consists of three phases. In the first phase, patient representatives and therapeutic radiographers participate in Experience-Based Co-Design to identify ways to improve communication during the radiotherapy review. In the second phase, various stakeholders, including members of the Society of Radiographers and of national patient representation groups, are consulted to develop a storyboard for the production of the communication training package. In the third phase, the acceptability and feasibility of the training is evaluated through observations, recruitment rates and follow-up discussions; a fidelity measure is designed; and potential benefits are observed, with patients' fear of cancer recurrence (FCR7) as the primary outcome. Secondary outcomes include a short daily measure of recurrence (FCR3), patients' positive and negative affect (PANAS), perceived empathy from the radiographer (CARE), satisfaction with the review meetings (RISS) and health-related quality of life (EQ-5D-3L).DiscussionTo date, there has been limited research on how communication between therapeutic radiographers and patients during review appointments can help to manage patients' recurrence fears during radiotherapy treatment. A collaborative and participatory approach to the development of a communication skills training will ensure that it is optimally targeted to the needs and preferences of both patients and radiographers. Targeting recurrence fears through communication at this stage, when patients are still in regular contact with healthcare providers, has the potential to reduce the need for complex interventions post-treatment.Trial registrationNRES reference: 18/LO/0669. Clinicaltrial.gov ID: NCT03468881.

Project description:BACKGROUND:In persons with type 1 diabetes (T1D), hypoglycemia is the major limiting factor in achieving optimal glycemic control. All persons with T1D are at risk for hypoglycemia (blood glucose level < 70 mg/dl), which is life-threatening and accompanied by serious physical and psychological symptoms, resulting in profound fear of hypoglycemia (FOH) and reduced quality of life. Young adults with T1D are at risk for FOH and have worse glycemic control and self-management behavior than other age groups with T1D. FOH also results in increased glycemic variability (GV). A major gap exists in how to manage FOH. Our overall objective is to reduce FOH and improve diabetes self-management, glycemic control, and GV in young adults with T1D to reduce or delay diabetes complications and improve quality of life. We aim to (1) determine the feasibility and acceptability of an eight-week cognitive behavioral therapy (CBT)-based Fear Reduction Efficacy Evaluation (FREE) intervention in young adults with T1D who experience FOH; and (2) determine the impact of the FREE intervention, compared to an attention control group, on the outcomes FOH, self-management, glycemic control (A1C), and glycemic variability (continuous glucose monitoring recordings). METHODS/DESIGN:A randomized controlled trial in 50 young adults aged 18 to 35 years with T1D will be used. Eligible subjects will be randomized to the intervention program (Fear Reduction Efficacy Evaluation [FREE]) or attention control group. A one-week run-in phase is planned, with baseline measures of FOH, self-management behavior, A1C, and real-time continuous glucose monitoring recordings (RT-CGM) to calculate GV for both groups. The intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears. RT-CGM and a daily FOH diary will be used as feedback cues as part of the FREE program. The attention control group will participate in eight weekly individual one-hour diabetes self-management education (DSME) sessions and wear a RT-CGM device (to measure GV only) over 8 weeks. At completion, FOH will be measured, and RT-CGM recordings will be analyzed to determine differences between the FREE and control groups. DISCUSSION:Findings from this proposed pilot study will serve as the foundation for a larger trial to reduce FOH and improve self-management, glycemic control, and GV. TRIAL REGISTRATION:ClinicalTrials.gov: A cognitive behavioral therapy (CBT) intervention to reduce fear of hypoglycemia in type 1 diabetes, NCT03549104. Registered June 7, 2018.

Project description:BACKGROUND: Many children with type 1 diabetes have poor glycaemic control. Since the Diabetes Control and Complications Trial (DCCT) showed that tighter control reduces complication rates, there has been more emphasis on intensified insulin therapy. We know that patients and families are afraid of hypoglycaemia. We hypothesised that fear of hypoglycaemia might take precedence over concern about long-term complications, and that behaviour to avoid hypoglycaemia might be at the cost of poorer control, and aimed to evaluate the effectiveness of any interventions designed to prevent that. The objective of this review was to systematically review studies concerning the extent and consequences of fear of hypoglycaemia in parents of children under 12 years of age with type 1 diabetes, and interventions to reduce it. METHODS: DATA SOURCES: MEDLINE, EMBASE, PsycINFO, The Cochrane Library, Web of Science, meeting abstracts of EASD, ADA and Diabetes UK, Current Controlled Trials, ClinicalTrials.gov, UK CRN, scrutiny of bibliographies of retrieved papers and contact with experts in the field.Inclusions: Relevant studies of any design of parents of children under 12 years of age with Type 1 diabetes were included. The key outcomes were the extent and impact of fear, hypoglycaemia avoidance behaviour in parents due to parental fear of hypoglycaemia in their children, the effect on diabetes control, and the impact of interventions to reduce this fear and hypoglycaemia avoidance behaviour. RESULTS: Eight articles from six studies met the inclusion criteria. All were cross sectional studies and most were of good quality. Parental fear of hypoglycaemia, anxiety and depression were reported to be common. There was a paucity of evidence on behaviour to avoid hypoglycaemia, but there were some suggestions that higher than desirable blood glucose levels might be permitted in order to avoid hypoglycaemia. No studies reporting interventions to reduce parental fear of hypoglycaemia were found. CONCLUSIONS: The evidence base was limited. Parents of children with Type 1 diabetes reported considerable parental fear of hypoglycaemia, affecting both parental health and quality of life. There is some suggestion that hypoglycaemia avoidance behaviours by parents might adversely affect glycaemic control. Trials of interventions to reduce parental anxiety and hypoglycaemia avoidance behaviour are needed. We suggest that there should be a trial of structured education for parents of young children with Type 1 diabetes.

Dataset Information

An Intervention to Reduce Hypoglycemia Fear in Parents of Young Kids with Type 1 Diabetes Through Video-Based Telemedicine (REDCHiP): Trial Design, Feasibility, and Acceptability.

Publications

An Intervention to Reduce Hypoglycemia Fear in Parents of Young Kids with Type 1 Diabetes Through Video-Based Telemedicine (REDCHiP): Trial Design, Feasibility, and Acceptability.

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