Promoting Partnership and Improving Self-Management for Children With Persistent Asthma

NCT03390556 | Completed

• 1 other identifier: RSRB00070365
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate a pilot of clinic-based intervention of asthma education. After a scheduled outpatient encounter for well-child care or asthma care has concluded, a pediatric nurse will teach participants (children and their caregivers) about asthma, provide clearly written information about how to manage asthma, and discuss how to manage asthma at home with cooperation between caregivers and children. Families will also receive current asthma prescriptions in clinic, and colored labels will be attached to medications in order to match the color scheme of asthma action plans (green labels for controller medications, red labels for rescue medications). Families will be followed for 3 months after the first clinic visit, including a follow-up visit in clinic 1 month later and a follow-up telephone call 3 months after starting. The nurse will reinforce key educational points and review medication use at the follow-up clinic visit. Families will also be invited to complete an additional in-depth interview following the 1 month clinic follow-up. The investigator hypothesizes that knowledge, self-efficacy, and reported adherence with asthma medications will increase for both caregivers and children/adolescents following the intervention and labeling of delivered medications. In addition, the investigator hypothesizes that children/adolescents will have more symptom free days and improved control following the intervention.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (4)

• Change in caregiver self-efficacy from baseline to 1 month and 3 month follow-up

  Parent asthma self-efficacy scale. This is a 13 item survey tool with 2 subscales: attack prevention (questions 1-6) and attack management (questions 7-13). For each question about perceived ability to manage asthma, parents select responses from a 5 point Likert scale (with 1 representing 'not at all sure' and 5 representing 'completely sure'). Responses to items in each subscale are averaged together to generate a subscale score. Higher mean subscale scores indicated increasing parent ability to perform asthma management tasks.

  Baseline, 1 month follow-up, 3 month follow-up

• Change in child self-efficacy from baseline to 1 month and 3 month follow-up

  Child asthma self-efficacy scale. This is a 14 item survey tool with 2 subscales: attack prevention (questions 1-8) and attack management (questions 9-14). For each question about perceived ability to manage asthma, children select responses from a 5 point Likert scale (with 1 representing 'not at all sure' and 5 representing 'completely sure'). Responses to items in each subscale are averaged together to generate a subscale score. Higher mean subscale scores indicated increasing child ability to perform asthma management tasks.

  Baseline, 1 month follow-up, 3 month follow-up

• Change in caregiver reported adherence from baseline to 1 month and 3 month follow-up

  Caregiver interview about adherence with controller medication over the previous 2 weeks. We will ask about the number of controller medication doses missed over the previous 2 weeks. As many children are instructed to use controller medications twice every day (once in the morning and once at night), the number of missed doses of controller medication ranges from 0 to 28 doses.

  Baseline, 1 month follow-up, 3 month follow-up

• Change in child reported adherence from baseline to 1 month and 3 month follow-up

  Child interview about adherence with controller medication over the previous 2 weeks. We will ask about the number of controller medication doses missed over the previous 2 weeks. As many children are instructed to use controller medications twice every day (once in the morning and once at night), the number of missed doses of controller medication ranges from 0 to 28 doses.

  Baseline, 1 month follow-up, 3 month follow-up

Secondary Outcomes (5)

• Changes in caregiver report of symptom free days from baseline to 1 month and 3 month follow-up

  Baseline, 1 month follow-up, 3 month follow-up

• Changes in child report of symptom free days from baseline to 1 month and 3 month follow-up

  Baseline, 1 month follow-up, 3 month follow-up

• Changes in caregiver assessment of asthma control from baseline to 1 month and 3 month follow-up (children 12 years and older).

  Baseline, 1 month follow-up, 3 month follow-up

• Changes in child assessment of asthma control from baseline to 1 month and 3 month follow-up (children 12 years and older).

  Baseline, 1 month follow-up, 3 month follow-up

• Changes in caregiver and child asthma control from baseline to 1 month and 3 month follow-up (children ages 7-11 years)

  Baseline, 1 month follow-up, 3 month follow-up

Study Arms (1)

Asthma education

EXPERIMENTAL

Other: Nurse-delivered education

Interventions

Nurse-delivered education OTHER

The nurse will: 1. Give the caregiver and child an overview of asthma, and discuss asthma control, triggers, and medications. 2. Give caregivers information about asthma management written at or below 6th grade reading levels. 3. Provide colored medication labels to distinguish controller from rescue medications following the action plan color scheme (green for controller medications, red for rescue medications). Teach-back methods will be used to elicit understanding of correct indications of use. 4. Demonstrate MDI/spacer technique with teach-back. 5. Discuss age-appropriate caregiver and child responsibility for asthma management within the family, with an overview of transitioning responsibility. 6. Ask patients to make a 1 month follow-up appointment for asthma care.

Asthma education

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Physician diagnosis of asthma, based on review of medical records.
• Uncontrolled asthma consistent with National Heart, Lung, and Blood Institute (NHLBI) guidelines, with at least 1 of the following based on caregiver report:
• a. If the child is 7-11 years old: i. An average of \>2 days per week with asthma symptoms ii. \>2 days per week with rescue medication use iii. \>2 days per month with nighttime symptoms iv. ≥2 episodes of asthma during the past year that have required systemic corticosteroids b. If the child is 12-14 years old: i. An average of \>2 days per week with asthma symptoms ii. \>2 days per week with rescue medication use iii. Nighttime symptoms 1-3 times per week iv. ≥2 episodes of asthma during the past year that have required systemic
• The child must have a current prescription (within the past year) of an inhaled asthma controller medication, such as an inhaled corticosteroid (ICS), based on review of electronic medical records.
• The child/adolescent is between ≥7 and ≤14 years old.
• The child/adolescent is insured by Medicaid or Medicaid managed care program.

You may not qualify if:

• An inability to speak and understand English. Parents and children with low literacy / health-literacy skills will be eligible, as survey instruments will be administered verbally and educational materials will be designed for low-literacy populations.
• No access to a working phone for follow-up, including care coordinator calls and the final follow-up survey.
• Another significant medical condition identified in the child's medical record that could interfere with assessment of asthma control, including Cystic Fibrosis, congenital heart disease, or other chronic pulmonary disease.
• A diagnosed developmental condition (e.g. Autism spectrum disorder or significant developmental delay) identified in the child's medical record that could impact the transition of responsibility for inhaled asthma medications from caregiver to child.
• If the child or family is currently enrolled in a study conducted by The Preventive Care Program for Urban Children with Asthma (led by Dr. Jill Halterman).

Sponsors & Collaborators

• University of Rochester: lead
• New York State Department of Health: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Study Officials

• Sean M Frey, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: January 4, 2018
• Study Start: June 7, 2018
• Primary Completion: May 31, 2019
• Study Completion: June 30, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)