Clinical trial NCT04904705: The Effect of the Cognitive Orientation to Daily Occupational Performance Approach for Children With Organic Acidemia
Official title: The Effect of the Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach for Children With Organic Acidemia on Daily Life Activities, Quality of Life and Participation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Organic Acidemia
Cognitive Orientation
Keywords: Organic Acidemia
Cognitive Orientation
Activities of Daily Living
Participation
Quality of Life
Telerehabilitation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 34
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion criteria:

* Children between the ages of 7-12
* Being diagnosed with organic acidemia
* Being able to read and write
* Having sufficient language skills to be able to communicate and be understood during the intervention

Exclusion criteria:

* Being on other treatment
* Having significant vision or hearing problems
* Refusing to participate in the study.

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: In the first week and the sixth week
measure: Quality of Life Questionnaire for Children (Kid-KINDL)
timeFrame: In the first week and the sixth week
measure: The Child and Adolescent Scale of Participation (CASP)
timeFrame: In the first week and the sixth week
measure: Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: In the first week and the sixth week
measure: Assistance to Participate Scale (APS)
timeFrame: In the first week and the sixth week
measure: Sociodemographic Questionnaire
timeFrame: In the first week
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altindag
Study officials:
affiliation: Hacettepe University
name: Gonca Bumin, Ph.D.
role: STUDY_DIRECTOR
References: