Parents in Transition - a Nurse-led Support and Transfer Education Program

NCT04969328 | Unknown DMC

• 1 other identifier: ParTNer-STEPs
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVE To improve chronically ill adolescents' transition to adult care by preparing and supporting the parents. The study aim is to improve parents' (of chronically ill adolescents, 16-18 years) transition readiness by offering them a brief transition program. HYPOTHESIS Young peoples´ self-management skills are mainly developed at home, guided by their parents, rather than in consultations with health professionals. The investigators hypothesize that a nurse-led transfer intervention focusing on parents' knowledge, skills and attitudes will:

1. 1.improve the parents´ readiness for their child's transition to adult health care
2. 2.support the parents' gradual handing over of treatment responsibility to the adolescent and, that an improvement in parental transition readiness will
3. 3.strengthen the adolescent's self-management skills and increase his/her readiness for transition.
4. 4.a website with information about the adult department and legal changes as well as advice from other parents and young people
5. 5.online teaching events (web based seminars) for parents
6. 6.transfer consultations across the paediatric and adult department

Conditions

Chronic Illness

Keywords

Adolescent; Chronically ill; Parents; Transitional care; Patient transfer

Outcome Measures

Primary Outcomes (1)

• Transition readiness (TR)

  TR measured by the questionnaire Medical self-management and transition readiness. The questionnaire is validated. The questionnaire consists of 21 identically structured Likert-scaled items assessing the adolescent's awareness of their health condition and ability to make decisions relevant to their health care needs. All items ask participants to respond on a five item Likert-scale (1=strongly disagree, 2=disagree, 3= neither disagree nor agree; 4=agree and 5= strongly agree). Answered by parents (primary) and adolescent (secondary outcome)

  Change from baseline TR at transfer (last consultation in paediatrics)

Secondary Outcomes (5)

• Allocation of Responsibility (AoR)

  Change from baseline AoR at transfer (last consultation in paediatrics)

• Uncertainty

  Change from baseline uncertainty score at transfer (last consultation in paediatrics)

• Health-related quality of life (HRQoL)

  Change from baseline HRQoL at transfer (last consultation in paediatrics)

• Experiences of transfer

  Three months after transfer (follow-up)

• Transfer satisfaction

  Three months after transfer (follow-up)

Study Arms (2)

ParTNer-STEPs

ACTIVE COMPARATOR

Parents and adolescents will receive the ParTNER-STEPs program and standard care.

Other: ParTNer-STEPs

Standard care

NO INTERVENTION

The adolescent and their parents will receive standard care

Interventions

ParTNer-STEPs OTHER

The intervention is a transfer program (ParTNer-STEPs), offered to the parents 1½ - ½ year before their child´s transfer to adult care. ParTNer-STEPs consist of 1. an informative website available for parents from recruitment until follow-up. 2. online educational events for parents. The teaching events are offered twice a year as a web based seminar with short presentations on different topics. The seminars will not be available for parents after their child has transferred to adult care. 3. transfer consultations across the paediatric and adult department. The transition consultations consist of: * a preparatory consultation (3-6 months before transfer) with the paediatric nurse. * a farewell consultation with the paediatric nurse (0-3 months before transfer). * a joint consultation (at transfer) where both the pediatrician and the adult physician will be present. * a welcoming consultation with the nurse from the adult care (0-3 months after transfer).

ParTNer-STEPs

Eligibility Criteria

• Age: 198 Months - 210 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parents, stepparents or guardians of chronically ill adolescents, who
• are aged 16.5-17.5 years (can be recruited up to six months before transfer)
• have been diagnosed for minimum six months
• have regular check-ups at the Department of Paediatrics and Adolescent Medicine's nephrology, hepatological, neurological and rheumatological outpatient clinics at Rigshospitalet, Denmark.
• are transferred to an adult hospital department
• are mentally and cognitively able to take responsibility for their own treatment

You may not qualify if:

• Parents who do not read and speak Danish
• Parents of adolescents who will be transferred to their family doctor at the age of 18 year.

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Center of Adolescent Medicine, Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Denmark.

Copenhagen, 2100, Denmark

Location

Related Publications (7)

• Bilhartz JL, Lopez MJ, Magee JC, Shieck VL, Eder SJ, Fredericks EM. Assessing allocation of responsibility for health management in pediatric liver transplant recipients. Pediatr Transplant. 2015 Aug;19(5):538-46. doi: 10.1111/petr.12466. Epub 2015 Mar 31.

  PMID: 25824486 BACKGROUND

• Burstrom A, Acuna Mora M, Ojmyr-Joelsson M, Sparud-Lundin C, Rydberg A, Hanseus K, Frenckner B, Nisell M, Moons P, Bratt EL. Parental uncertainty about transferring their adolescent with congenital heart disease to adult care. J Adv Nurs. 2019 Feb;75(2):380-387. doi: 10.1111/jan.13852. Epub 2018 Oct 18.

  PMID: 30209810 BACKGROUND

• Schwartz LA, Brumley LD, Tuchman LK, Barakat LP, Hobbie WL, Ginsberg JP, Daniel LC, Kazak AE, Bevans K, Deatrick JA. Stakeholder validation of a model of readiness for transition to adult care. JAMA Pediatr. 2013 Oct;167(10):939-46. doi: 10.1001/jamapediatrics.2013.2223.

  PMID: 23959392 BACKGROUND

• Williams T, Sherman E, Mah JK, et al. (2011) Measurement of medical self-management and transition readiness among Canadian adolescents with special health care needs. International Journal of Child and Adolescent Health 3: 527-535.

  BACKGROUND

• Schwartz LA, Tuchman LK, Hobbie WL, Ginsberg JP. A social-ecological model of readiness for transition to adult-oriented care for adolescents and young adults with chronic health conditions. Child Care Health Dev. 2011 Nov;37(6):883-95. doi: 10.1111/j.1365-2214.2011.01282.x.

  PMID: 22007989 BACKGROUND

• Thomsen EL, Boisen KA, Hanghoj S, Hansson H, Grabow Scheelhardt HV, Christensen ST, Esbensen BA. A comprehensive transfer program from pediatrics to adult care for parents of adolescents with chronic illness (ParTNerSTEPs): study protocol for a randomized controlled trial. Trials. 2022 Dec 20;23(1):1034. doi: 10.1186/s13063-022-06997-0.

  PMID: 36539857 DERIVED

• Thomsen EL, Esbensen BA, Hanghoj S, Hansson H, Boisen KA. Development of a complex intervention to support parents of adolescents with chronic illness transferring from pediatrics to adult care (ParTNerSTEPs). BMC Health Serv Res. 2022 Apr 12;22(1):485. doi: 10.1186/s12913-022-07888-5.

  PMID: 35413976 DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bente A Esbensen, Professor

  Center of Rheumatology and Spine Disorders, Copenhagen University Hospital, Rigshospitalet, Denmark

  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: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Senior Researcher, RN, MSciN, Ph.D

Model Details: The study has a RCT design and consist of a intervention- and a control group (1:1). The study is part of a complex intervention design consisting of four phases: development, pilot testing, evaluation and implementation. The RCT study is together with a qualitative process evaluation part of the evaluation phase.

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 20, 2021
• Study Start: July 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)