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Parents in Transition - a Nurse-led Support and Transfer Education Program (ParTNer-STEPs)

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ClinicalTrials.gov Identifier: NCT04969328
Recruitment Status : Recruiting
First Posted : July 20, 2021
Last Update Posted : July 20, 2021
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Bente Appel Esbensen, Glostrup University Hospital, Copenhagen

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. improve the parents´ readiness for their child's transition to adult health care
  2. support the parents' gradual handing over of treatment responsibility to the adolescent and, that an improvement in parental transition readiness will
  3. strengthen the adolescent's self-management skills and increase his/her readiness for transition.

BACKGROUND Transfer from paediatric to adult care for chronically ill adolescents is associated with no-shows and low treatment adherence, as well as anxiety and concerns among parents. Studies show that support for parents results in better transition for both parties.

INTERVENTION

ParTNer-STEPs is a transfer program consisting of three initiatives:

  1. a website with information about the adult department and legal changes as well as advice from other parents and young people
  2. online teaching events (web based seminars) for parents
  3. transfer consultations across the paediatric and adult department

METHOD The intervention will be evaluated in a randomized controlled trial (RCT) study over two years. The project will be carried out in four paediatric outpatient clinics at Rigshospitalet, Copenhagen University Hospital, Denmark: nephrology, hepatology, neurology and rheumatology. Based on a power calculation, the investigators aim to include parents of minimum 62 adolescents. Primary outcome: Parents' transition readiness (TR). Secondary outcomes: Adolescents' TR, self-management skills, and quality of life.


Condition or disease Intervention/treatment Phase
Chronic Illness Other: ParTNer-STEPs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: ParTNer-STEPs: Parents in Transition - a Nurse-led Support and Transfer Education Program
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : August 1, 2023

Arm Intervention/treatment
Active Comparator: ParTNer-STEPs
Parents and adolescents will receive the ParTNER-STEPs program and standard care.
Other: ParTNer-STEPs

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).

No Intervention: Standard care
The adolescent and their parents will receive standard care



Primary Outcome Measures :
  1. Transition readiness (TR) [ Time Frame: Change from baseline TR at transfer (last consultation in paediatrics) ]
    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)


Secondary Outcome Measures :
  1. Allocation of Responsibility (AoR) [ Time Frame: Change from baseline AoR at transfer (last consultation in paediatrics) ]
    AoR measured by the questionnaire Allocation of Responsibility. The questionnaire is validated and consists of 13 items. Participants answer questions on self-report measures. Respondents can choose from one of four answers: 1) parent/guardian takes primary responsibility, 2) responsibility is shared between the parent/guardian and the adolescent, 3) adolescent takes primary responsibility or 4) Not Applicable or No One Does This. Answered by parents and adolescents.

  2. Uncertainty [ Time Frame: Change from baseline uncertainty score at transfer (last consultation in paediatrics) ]
    Uncertainty measured by the uncertainty-scale. The scale is validated and measures parental uncertainty during transfer of their child from paediatric to adult care on a linear analogue scale from 0 (not uncertain at all) to 100 (extremely uncertain). Answered by parents

  3. Health-related quality of life (HRQoL) [ Time Frame: Change from baseline HRQoL at transfer (last consultation in paediatrics) ]
    HRQoL measured by EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Answered by adolescents

  4. Experiences of transfer [ Time Frame: Three months after transfer (follow-up) ]
    Experiences of transfer measured by a self-developed questionnaire with 11 items based on modifiable factors from the SMART transition theory. All items ask participants to respond on a five item Likert-scale (1=strongly disagree, 2=disagree, 3= partially agree; 4=agree and 5= strongly agree). The questionnaire has been content and face validated by parents . Answered by parents

  5. Transfer satisfaction [ Time Frame: Three months after transfer (follow-up) ]
    Transfer satisfaction measured by a single question: 'On a scale of 0-100, how satisfied have participants been with their child's transition to the adult care?' The scale is a linear analogue scale from 0 (very unsatisfied) to 100 (very satisfied). Answered by parents and adolescents.



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Ages Eligible for Study:   198 Months to 210 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04969328


Contacts
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Contact: Bente A Esbensen, Professor +45 38634056 ext +45 24412490 bente.appel.esbensen@regionh.dk
Contact: Ena L Thomsen, PhD-student +45 35451171 ext +45 23814776 ena.lindhart.thomsen@regionh.dk

Locations
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Denmark
Center of Adolescent Medicine, Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Denmark. Recruiting
Copenhagen, Denmark, 2100
Contact: Ena L Thomsen, PhD student    + 45 35451171 ext +45 23814776    ena.lindhart.thomsen@regionh.dk   
Contact: Kirsten A Boisen, PhD, MD    +45 35451186    kirsten.arntz.boisen@regionh.dk   
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Bente A Esbensen, Professor Center of Rheumatology and Spine Disorders, Copenhagen University Hospital, Rigshospitalet, Denmark
  Study Documents (Full-Text)

Documents provided by Bente Appel Esbensen, Glostrup University Hospital, Copenhagen:
Study Protocol  [PDF] July 9, 2021

Publications:
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Responsible Party: Bente Appel Esbensen, Professor, Senior Researcher, RN, MSciN, Ph.D, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT04969328    
Other Study ID Numbers: ParTNer-STEPs
First Posted: July 20, 2021    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Full dataset to replicate the analysis will be available from the corresponding author on reasonable request until five years after completion of the study, according to Danish law.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bente Appel Esbensen, Glostrup University Hospital, Copenhagen:
Adolescent
Chronically ill
Parents
Transitional care
Patient transfer
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes