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

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ClinicalTrials.gov Identifier: NCT02641275
Recruitment Status : Not yet recruiting
First Posted : December 29, 2015
Last Update Posted : October 25, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

November 9, 2015
December 29, 2015
October 25, 2016
January 2017
December 2018   (Final data collection date for primary outcome measure)
  • Action Orientation Questionnaire (HAKEMP) [ Time Frame: 1 1/2 year with control group ]
    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) [ Time Frame: 1 1/2 year with control group ]
    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) [ Time Frame: 1 1/2 year with control group ]
    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.
Same as current
Complete list of historical versions of study NCT02641275 on ClinicalTrials.gov Archive Site
Number of Participants With Sum of Abnormal Laboratory Values Concerning Biomarkers of psychosocial stress [ Time Frame: 1 1/2 year with control group ]
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.
Same as current
Not Provided
Not Provided
 
Self-management Training for Parents With Chronic Muscular Dystrophia
Self-management Training for Parents With Chronic Muscular Dystrophia
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Muscular Dystrophies
Other: Structured self-management-training
Structured self-management-training (incl. systemic analysis, coaching, teaching) in 4 sessions
  • Experimental: Intervention
    Structured self-management-training (incl. systemic analysis, coaching, teaching) in 4 sessions.
    Intervention: Other: Structured self-management-training
  • No Intervention: Control group
    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).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
December 2019
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact: Jürg C Streuli, MD PhD 0041787331831 juerg.streuli@kispi.uzh.ch
Not Provided
 
 
NCT02641275
ZRM-CMD Parents
No
Not Provided
Not Provided
University Children's Hospital, Zurich
University Children's Hospital, Zurich
University of Zurich
Principal Investigator: Jürg C Streuli, MD PhD University Children's Hospital, Zurich
University Children's Hospital, Zurich
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP