FLIGHT Intervention for Chronic Illness

Overseen By Study Coordinator

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Documenting Hope Project

Disqualifiers: Severe condition, Caregiver health, Environmental toxicants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

14 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the study team to get a clear answer.

What data supports the effectiveness of the FLIGHT Intervention treatment for chronic illness?

Educational programs and interventions, like those used for asthma, have shown to reduce symptoms and improve management of chronic conditions in children. For example, the Aironet program reduced asthma attacks and improved parents' knowledge, while a novel asthma camp intervention led to fewer school absences and hospital visits. ^{1 2 3 4 5}

How is the FLIGHT Intervention treatment different from other treatments for childhood chronic illness?

The FLIGHT Intervention is unique because it combines personalized lifestyle changes and multimodal approaches to address childhood chronic illnesses, focusing on improving overall health rather than just managing symptoms. This approach is different from traditional treatments that often focus solely on medical management without integrating lifestyle and family dynamics. ^{1 6 7 8 9}

What is the purpose of this trial?

The FLIGHT study is an open-label, single-arm, pilot and feasibility study of a personalized and multimodality intervention focusing upon modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care for children with chronic illness. A mixed methods outcomes evaluation will be performed. The primary goal of this study is to evaluate the most feasible and promising strategies to inform a more streamlined and scalable intervention in the future. Up to 14 participants may be enrolled, but fewer are expected to achieve the primary goal of the study.

Eligibility Criteria

The FLIGHT study is for children with chronic illness, including those with multiple health conditions. It aims to improve their well-being through lifestyle changes and environmental adjustments, guided by a team of experts. Children must be able to participate in the intervention and assessments.

Inclusion Criteria

Participant and participant's caregiver must reside in the United States and live within the designated recruitment areas

Verified completion of the CHIRP survey and consent to participate in the FLIGHT Study screening process

At least one guardian must have the ability to read and write English

Exclusion Criteria

Caregiver(s) with health or other life circumstances that preclude full participation in the intensive intervention

Inability to control/modify child's diet at daycare or with childcare provider

Candidate is pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a personalized and multimodality intervention focusing on modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care

18 months

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• FLIGHT Intervention

Trial Overview This pilot study tests the FLIGHT Intervention—a personalized program that combines lifestyle modifications and specialized clinical care—to see which strategies work best for kids with chronic diseases.

Participant Groups

Group I: FLIGHT Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Documenting Hope Project

Lead Sponsor

Trials

1

Recruited

10+

Findings from Research

The Aironet educational program significantly reduced the number of asthma attacks in children with intermittent or mild persistent asthma, with an average of 1.65 attacks in the education group compared to 2.34 in the control group over 12 months.

Parents of children who experienced three or more asthma attacks at baseline showed a greater improvement in their knowledge of asthma after participating in the Aironet program, highlighting its effectiveness in both managing the disease and educating families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effects of a Long-term Educational Program for children with asthma - Aironet. A 1-yr randomized controlled trial. Indinnimeo, L., Bonci, E., Capra, L., et al.[2009]

The pilot program by the American Lung Association successfully educated 84 urban black asthmatic children, leading to a significant reduction in school absences, emergency room visits, and hospitalizations by 36% to 69%.

Follow-up interviews indicated that the majority of participants adopted new asthma management techniques, such as using inhalers (78%) and practicing breathing exercises (55%), demonstrating the program's effectiveness in teaching daily management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel asthma camp intervention for childhood asthma among urban blacks. The Pediatric Lung Committee of the American Lung Association of the District of Columbia (ALADC) Washington, DC. Fitzpatrick, SB., Coughlin, SS., Chamberlin, J.[2022]

A novel nurse telephone coaching intervention was tested in a randomized, controlled trial to improve asthma self-management for parents of children aged 5 to 12 with persistent asthma.

Despite existing guidelines, maintenance asthma care remains inadequate, highlighting the need for effective support systems like this coaching intervention to enhance care and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telephone coaching intervention to improve asthma self-management behaviors. Swerczek, LM., Banister, C., Bloomberg, GR., et al.[2022]

Inpatient medical rehabilitation significantly improved disease-related self-management in children with obesity (n=706) and bronchial asthma (n=162), with a strong effect size in the obesity group (SRM=0.84) and a moderate effect in the asthma group (SRM=0.42).

For children with bronchial asthma, effective self-management after rehabilitation was strongly predicted by their initial self-management skills, while the predictors for the obesity group were less clear, suggesting that different factors may influence treatment success in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Disease-related self-management of obese children and children with bronchial asthma: changes and predictors during inpatient rehabilitation]. Gustke, M., Petermann, F., Farin, E.[2011]

A systematic review of 18 studies found that while some psychosocial interventions, particularly asthma education and art therapy, can lead to significant improvements in health-related quality of life (HRQOL) for asthmatic children, the overall evidence for effectiveness is limited.

Most interventions focused on asthma education without addressing family dynamics, suggesting that future programs should combine education with strategies to enhance family involvement in asthma management to better improve HRQOL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of psychosocial interventions designed to improve health-related quality of life (HRQOL) amongst asthmatic children and their families: a systematic review. Clarke, SA., Calam, R.[2021]

Parents of children with chronic illnesses often focus more on managing the illness rather than promoting overall health, which can lead to imbalances in health promotion efforts.

Families face additional health risks that require significant lifestyle adjustments, including changes in nutrition, exercise, and coping strategies, highlighting the need for comprehensive support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health promotion during childhood chronic illness: a paradox facing society. Heinzer, MM.[2019]

A personalized, web-based asthma education program was developed for parents of children aged 4 to 12 with moderate to severe asthma, incorporating tailored messages and support from a human coach to enhance asthma self-management skills.

The program includes features like an Asthma Manager and monthly phone calls from an asthma-nurse case manager, and is currently being evaluated in a randomized study to assess its effectiveness in improving medication adherence, asthma control, and parent quality of life over a year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet telehealth for pediatric asthma case management: integrating computerized and case manager features for tailoring a Web-based asthma education program. Wise, M., Gustafson, DH., Sorkness, CA., et al.[2023]

Family interventions for managing chronic health problems show promise, particularly in improving communication and problem-solving skills among families dealing with illnesses like cancer and diabetes.

Most studies reviewed focused on time-limited therapeutic interventions rather than family psychotherapy models, indicating a need for more research on effective family-based approaches to support patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Couple and family interventions in health problems. Shields, CG., Finley, MA., Chawla, N., et al.[2022]

Both face-to-face and Internet videoconferencing methods of delivering Behavioral Family Systems Therapy for Diabetes (BFST-D) showed no significant differences in effectiveness for improving adherence and glycemic control among adolescents with type 1 diabetes, based on a study involving participants aged 12 to 18 over 12 weeks.

Overall, BFST-D led to significant improvements in adherence and glycemic control from before to after the intervention, with these benefits maintained at a 3-month follow-up, indicating that Internet-based therapy is a viable option for families facing barriers to traditional care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seeing Is Believing: Using Skype to Improve Diabetes Outcomes in Youth. Harris, MA., Freeman, KA., Duke, DC.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical effects of a Long-term Educational Program for children with asthma - Aironet. A 1-yr randomized controlled trial. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

A novel asthma camp intervention for childhood asthma among urban blacks. The Pediatric Lung Committee of the American Lung Association of the District of Columbia (ALADC) Washington, DC. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A telephone coaching intervention to improve asthma self-management behaviors. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Disease-related self-management of obese children and children with bronchial asthma: changes and predictors during inpatient rehabilitation]. [2011]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The effectiveness of psychosocial interventions designed to improve health-related quality of life (HRQOL) amongst asthmatic children and their families: a systematic review. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Health promotion during childhood chronic illness: a paradox facing society. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Internet telehealth for pediatric asthma case management: integrating computerized and case manager features for tailoring a Web-based asthma education program. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Couple and family interventions in health problems. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Seeing Is Believing: Using Skype to Improve Diabetes Outcomes in Youth. [2018]