search
Back to results

Self-management Training for Parents With Chronic Muscular Dystrophia (ZRM-CMD-P)

Primary Purpose

Muscular Dystrophies

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Structured self-management-training
Sponsored by
University Children's Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Muscular Dystrophies focused on measuring Parental stress, Muscular Dystrophies, Coping, Parental support

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Parents with at least one living child affected by chronic muscular dystrophy

Exclusion Criteria:

  • Dying of a child during intervention and analysis.
  • Severe/significant psychological disorder (in case of existing psychological support, participation should be agreed/supported by therapist, too)
  • Recent or concomitant self-management training

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control group

    Arm Description

    Structured self-management-training (incl. systemic analysis, coaching, teaching) in 4 sessions.

    no intervention other than existing support (see exclusion criteria). However, intervention will be offered and studied secondary as well (after 1 1/2 year of no intervention).

    Outcomes

    Primary Outcome Measures

    Action Orientation Questionnaire (HAKEMP)
    Kuhl and co-workers introduced a special questionnaire (HAKEMP) to assess the tendency of people in concrete situations to revert to an action-oriented or state-oriented condition in 24 items.
    Self-efficacy: Thought control of action (SWE)
    Quantify improved parental resilience and coping strategies facing chronic stress. Questionnaire developed by Jerusalem and Schwarzer, 1981, revised 1999 to test general self-efficacy in 10 items.
    Change in Experiencing and Behaviour post-intervention (VEV)
    VEV is a questionnaire developed by Ziele and Kopf-Mehnert, 1978 to test post-intervention change in experiencing and behavior along with a retrospective life-event checklist and a self-rating questionnaire in 42 items. Other than previous questionnaires VEV will be applied only after intervention.

    Secondary Outcome Measures

    Number of Participants With Sum of Abnormal Laboratory Values Concerning Biomarkers of psychosocial stress
    Significant lower levels of biomarkers of psychosocial stress, i.e. pro-inflammatory cytokines, which can be used to monitor physiological changes with assumed significance for parental health: C-reactive Protein (hsCRP), Tumor-Necrose-Factor alpha (TNFα), Interleukin (IL)-1ß, IL-6, und Interferon Gamma (IFNγ). Items will be aggregated as a numerical factor which shows the difference of a measured value from a reference value . Abnormal laboratory values therefore will be used as a sum.

    Full Information

    First Posted
    November 9, 2015
    Last Updated
    August 14, 2019
    Sponsor
    University Children's Hospital, Zurich
    Collaborators
    University of Zurich
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02641275
    Brief Title
    Self-management Training for Parents With Chronic Muscular Dystrophia
    Acronym
    ZRM-CMD-P
    Official Title
    Self-management Training for Parents With Chronic Muscular Dystrophia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    We could not enrole or recruite enough participants.
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Children's Hospital, Zurich
    Collaborators
    University of Zurich

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The relentless progressive process of muscular dystrophy requires extraordinary medical, physical, and emotional care with severe consequences for caring parents (increased stress and diminished social, psychological and physical well-being). Despite the obvious need of support for parents only few and weak data exist regarding efficiency and efficacy of specific interventions supporting parental resilience and coping strategies. The presenting study aims to fill this gap by evaluating the efficacy of a structured self-management training for parents of children with severe progressive muscular dystrophy compared to parents receiving treatment as usual (TAU). In addition, investigators measure established biomarkers of psychosocial stress, such as pro-inflammatory cytokines, which will be used to monitor physiological changes with assumed significance for parental health.
    Detailed Description
    Background: The relentless progressive process of muscular dystrophy requires extraordinary medical, physical, and emotional care. As a consequences caring for a patient with a severe chronic illness has been associated with increased stress and diminished social, psychological and physical well-being in parents. According to Thompson et al. 57% of parents with Duchenne muscular dystrophy children have self-reported poor psychological adjustment and, even in comparison with parents of children with other burdens like cerebral palsy or renal diseases, muscular dystrophy was associated with a wider spectrum of problems and parental stress. Moreover, parents are shown to have significant stress by feelings of guilt and associated difficulty discussing death issues with their children. However, despite the obvious need of support for parents only few and weak data exist regarding efficiency and efficacy of specific interventions supporting parental resilience and coping strategies. In practice, they are mostly limited to meetings of self-help groups and casual exchange between concerned parents, which is rather a problem-centered than proactive solution-focused approach. As a consequence, investigators see a great need for studies regarding more specific interventions supporting parents' self-management skills, coping strategies and competencies. Objectives: The present study evaluates the efficacy of a structured self-management training for parents of children with severe progressive muscular dystrophy compared to parents receiving treatment as usual (TAU). In addition, investigators measure established biomarkers of psychosocial stress, such as pro-inflammatory cytokines, which will be used to monitor physiological changes with assumed significance for parental health. Methods: Participants will fill out online-questionnaires before, during and after self-management training. Training interventions will take place in Zurich as group sessions (10-20 participants per group). Investigators aim for a total of 60-80 participants. Parent-couples or single participants will be randomized in an intervention group (participants receiving self-management training) and a non-intervention group (participants continue with already established support). After one year parents from the non-intervention group will change into the intervention group with self- management training as well. Questionnaires focus on assessing parental strain and self- efficacy and will take 30-45minutes for each of four surveys. Validated biological markers such as cumulative cortisol levels in hair and pro-inflammatory cytokines in the blood will be collected before and after self-management trainings.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Muscular Dystrophies
    Keywords
    Parental stress, Muscular Dystrophies, Coping, Parental support

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Structured self-management-training (incl. systemic analysis, coaching, teaching) in 4 sessions.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    no intervention other than existing support (see exclusion criteria). However, intervention will be offered and studied secondary as well (after 1 1/2 year of no intervention).
    Intervention Type
    Other
    Intervention Name(s)
    Structured self-management-training
    Intervention Description
    Structured self-management-training (incl. systemic analysis, coaching, teaching) in 4 sessions
    Primary Outcome Measure Information:
    Title
    Action Orientation Questionnaire (HAKEMP)
    Description
    Kuhl and co-workers introduced a special questionnaire (HAKEMP) to assess the tendency of people in concrete situations to revert to an action-oriented or state-oriented condition in 24 items.
    Time Frame
    1 1/2 year with control group
    Title
    Self-efficacy: Thought control of action (SWE)
    Description
    Quantify improved parental resilience and coping strategies facing chronic stress. Questionnaire developed by Jerusalem and Schwarzer, 1981, revised 1999 to test general self-efficacy in 10 items.
    Time Frame
    1 1/2 year with control group
    Title
    Change in Experiencing and Behaviour post-intervention (VEV)
    Description
    VEV is a questionnaire developed by Ziele and Kopf-Mehnert, 1978 to test post-intervention change in experiencing and behavior along with a retrospective life-event checklist and a self-rating questionnaire in 42 items. Other than previous questionnaires VEV will be applied only after intervention.
    Time Frame
    1 1/2 year with control group
    Secondary Outcome Measure Information:
    Title
    Number of Participants With Sum of Abnormal Laboratory Values Concerning Biomarkers of psychosocial stress
    Description
    Significant lower levels of biomarkers of psychosocial stress, i.e. pro-inflammatory cytokines, which can be used to monitor physiological changes with assumed significance for parental health: C-reactive Protein (hsCRP), Tumor-Necrose-Factor alpha (TNFα), Interleukin (IL)-1ß, IL-6, und Interferon Gamma (IFNγ). Items will be aggregated as a numerical factor which shows the difference of a measured value from a reference value . Abnormal laboratory values therefore will be used as a sum.
    Time Frame
    1 1/2 year with control group

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Parents with at least one living child affected by chronic muscular dystrophy Exclusion Criteria: Dying of a child during intervention and analysis. Severe/significant psychological disorder (in case of existing psychological support, participation should be agreed/supported by therapist, too) Recent or concomitant self-management training
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jürg C Streuli, MD PhD
    Organizational Affiliation
    University Children's Hospital, Zurich
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Self-management Training for Parents With Chronic Muscular Dystrophia

    We'll reach out to this number within 24 hrs