The Effect of the Cognitive Orientation to Daily Occupational Performance Approach for Children With Organic Acidemia
Condition: Organic Acidemia; Cognitive Orientation
MeSH terms: Acidosis
Study type: Interventional

Summary: 
      The aim of this study is to research the effect of Cognitive Orientation to daily
      Occupational Performance (the CO-OP Approach) on daily life activities, quality of life and
      participation in children with organic acidemia.

      The hypotheses of the study are as follows:

        -  Cognitive Orientation to daily Occupational Performance (the CO-OP Approach) applied to
           children with organic acidemia has no effect on daily life activities.

        -  Cognitive Orientation to daily Occupational Performance (the CO-OP Approach) applied to
           children with organic acidemia has no effect on quality of life.

        -  Cognitive Orientation to daily Occupational Performance (the CO-OP Approach) applied to
           children with organic acidemia has no effect on participation.
    

Detailed description: 
      Organic acidemia is an inherited metabolic diseases due to the deficiency of an enzyme or a
      transport protein involved in one of the several cellular metabolic pathways devoted to the
      catabolism of amino acids, carbohydrates, or lipids. Collectively, their incidence
      approximates 1 out of 3000 live births. Moreover, the demanding medical management of organic
      acidemia patients often dominates the efforts of their metabolic teams, impacting on time
      dedicated toward addressing aspects of care that could enhance functional independence and
      improve quality of life. While most published data on long-term organic acidemia outcomes
      have focused on medical endpoints such as survival and neurocognition, there have been fewer
      efforts to document functionality, independence, and social integration or the need for
      rehabilitation interventions that could maintain and maximize function. It's understood that
      delivering one form of meta-cognitive strategy training, the CO-OP approach, using a
      telerehabilitation format is feasible and shows similar positive effects to face-to-face
      delivery.

      It was planned to include children between the ages of 7-12 who were diagnosed with organic
      acidemia in this study. In consequence of the statistical power analysis, the number of
      individuals to participate in the study was determined as 34 children diagnosed with organic
      acidemia, including 17 in the intervention group and 17 in the control group. The study will
      be conducted in a randomized controlled method. Children will be divided into intervention
      and control groups by using a computer-assisted online randomization application that
      provides an equal number and probability. Participants will be randomly numbered and randomly
      assigned to the intervention or control group without repeating the same number with the
      online randomization application available at randomizer.org. Both groups will be given a
      home program. Home programs will be prepared and sent to the person via e-mail. The Cognitive
      Orientation for Daily Activity Performance (CO-OP) Approach to the intervention group will be
      applied by video conferencing method in a total of 10 sessions, 2 sessions per week, through
      5 weeks, and a total of 12 sessions with initial and final evaluations.

      The children to be included in our study will be determined among the children with organic
      acidemia who are directed from Hacettepe University Metabolism and Nutrition Department. The
      contact information of the volunteers who agree to participate in the study will be given to
      the occupational therapist. The occupational therapist will provide information on how to
      download and use the video interview program called Zoom on his/her phone or computer. The
      session schedule will be determined after the program is set up. The program named Zoom was
      preferred because it is free, easy to install, and accessible compared to the other video
      conference programs.

      The informed consent form will be sent to the individuals online by using Google Forms. After
      the participants approve the consent form, they will reach the evaluations to be prepared on
      Google Forms. One of the evaluation scales, the Canadian Occupational Performance Measure
      (COPM) will be made over the video interview. If they do not want to approve the consent
      form, they will be exempted from the study by checking the "I do not approve" option.

      In this study, Canadian Occupational Performance Measure (COPM), Pediatric Evaluation of
      Disability Inventory (PEDI), The Child and Adolescent Scale of Participation (CASP), Quality
      of Life Questionnaire for Children (Kid-KINDL), Assistance to Participate Scale, and
      Sociodemographic Questionnaire will be implemented.
    

Intervention name(s): The Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach; Home Program
Intervention type(s): Other; Other
Intervention description(s): The Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach is a cognitive-based approach. This is a person-oriented, performance-solving problem-solving approach that enables strategy acquisition and guided exploration for the acquisition and learning of new skills.
The main objectives of this approach are; define and transfer domain-specific strategies to other motor-based tasks to gain skills, learn problem-solving strategy (goal, plan, do, check) and adapt to other environments (such as home, school).; Home Program are activities that a participant can apply at home to improve their skills.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In consequence of the statistical power analysis, the number of individuals to participate in the study was determined as 34 children diagnosed with organic acidemia, including 17 in the intervention group and 17 in the control group. The study will be conducted in a randomized controlled method. Children will be divided into intervention and control groups by using a computer-assisted online randomization application. Participants will be randomly numbered and randomly assigned to the intervention or control group without repeating the same number with the online randomization application available at randomizer.org. Both groups will be given a home program that will be prepared and sent to the person via e-mail. The Cognitive Orientation for Daily Occupational Performance (CO-OP) Approach to the intervention group will be applied by video conferencing method in a total of 10 sessions, 2 sessions per week, through 5 weeks, and a total of 12 sessions with initial and final evaluations.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Organic Acidemia; Cognitive Orientation; Activities of Daily Living; Participation; Quality of Life; Telerehabilitation