NCT01750892

Brief Summary

This study is looking at ways to help young people with chronic health conditions take better care of their health and find an adult doctor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

1.7 years

First QC Date

December 13, 2012

Last Update Submit

October 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Successful transition to an adult provider

    The primary outcome is successful transition to an adult provider, as evidenced by at least 1 visit with an adult provider within 10 months of the baseline visit.

    10 months

Secondary Outcomes (1)

  • Increased self-care and transition related skills

    6 months

Other Outcomes (1)

  • Participant satisfaction with the intervention

    6 months

Study Arms (4)

Group 1: Control

ACTIVE COMPARATOR

Group 1 will be the control group. They will complete questionnaires but will otherwise receive usual care from their Primary Care Provider (PCP). At the end of the study period they will be given the Study Materials for participating.

Other: Study Materials

Group 3: Group Intervention

EXPERIMENTAL

Group 3 (Group Intervention) will receive the Study Materials at the beginning of the study and will also be invited to attend two REACH for Independence group sessions.

Behavioral: REACH for IndependenceOther: Study Materials

Group 4: Full Intervention

EXPERIMENTAL

Group 4 (Full Intervention) will receive the Study Materials at the beginning of the study, will be invited to attend the REACH for Independence group sessions, and will be invited to a Transition Consult with an MD and social worker.

Behavioral: REACH for IndependenceBehavioral: Transition ConsultOther: Study Materials

Group 2: Basic Intervention

EXPERIMENTAL

Group 2 (Basic Intervention) will receive the Study Materials at the beginning of the study but will otherwise continue with their usual PCP care.

Other: Study Materials

Interventions

REACH for Independence is a transition and self-care skill-building peer support group led by a social worker. It is comprised of two 2.5-hour group sessions where participants participate in activities designed to teach self-care, self-advocacy and improve transition to adulthood skills.

Group 3: Group InterventionGroup 4: Full Intervention

The transition consult is a 1-on-1 visit with an MD and social worker. At the consults, participants will receive individualized information related to their unique medical and psychosocial needs and support related to issues relevant to their gaining healthcare independence and finding an adult doctor, such as accommodations, transportation, insurance and finances. After the consult, this group will have access to a transition coordinator who can help with any transition-related problems that may occur.

Group 4: Full Intervention

The Study Materials include a Care Binder, a Resource list, an Adult Doctor List and a Wallet Card. The Care Binder is an organizational tool to help patients with special healthcare needs manage and track important information related to their health and medical care. The Resource list has information about important community resources. The Adult Doctor List provides information about finding an adult primary care provider. The Wallet Card is a sheet for tracking important medical and personal information.

Group 1: ControlGroup 2: Basic InterventionGroup 3: Group InterventionGroup 4: Full Intervention

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females age 19 years of age or older
  • Presence of at least 1 Chronic Condition and/or Cognitive Disability
  • Last visit with pediatric primary care provider occurring on or after January 1, 2011
  • Currently active in one of four identified pediatric practices (Cobbs Creek, Chestnut Hill, Market Street, West Chester)
  • Current primary care provider approval for participation
  • English speaking

You may not qualify if:

  • Male or female age \< 19 years
  • No presence of a chronic condition or cognitive disability
  • Last visit with pediatric PCP occurring prior to January 1, 2011
  • Not currently active in one of four identified pediatric practices (Cobbs Creek, Chestnut Hill, Market Street, West Chester)
  • Current PCP disapproves participation
  • Non-English speaking
  • Has a child enrolled in the study
  • Child has consented/assented to allow them to participate
  • English speaking
  • Child did not consent/assent to allow them to participate
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

  • Nadja Peter, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR
  • Oana Tomescu, MD, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 17, 2012

Study Start

October 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 13, 2023

Record last verified: 2023-10

Locations