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IRCT20221013056164N1 IRCT 2022-11-15 Shahid Beheshti University of Medical Sciences Effectiveness of Integrated Psycho-Spiritual Care Package on Self-Efficacy, Self-Care and Health-Related Quality of Life of Adults with Type 2 Diabetes. Assessing the Effectiveness of Integrated Psycho-Spiritual Care Package on Self-Efficacy, Self-Care and Health-Related Quality of Life in Adults with Type 2 Diabetes. 2023-02-20 anticipated 118 Complete https://irct.ir/trial/66395 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: The study includes two groups (control and intervention). During the study, the intervention group will receive all three components: psychological care, spiritual care, and physical self-care in diabetes (Integrated Psycho-Spiritual Care Package). The control group will only receive the physical self-care component in diabetes, Randomization description: Following the selection of a comprehensive health service center via convenience sampling; the sampling will be random. Based on a list of contact information for individuals with Type 2 diabetes extracted from the electronic health records of the SIB system, and by contacting individuals to assess eligibility criteria, Participants will be selected from the list using a systematic random sampling method, alternating between the control and intervention groups. This process will continue until the sample size for each group is complete. The first individual will be assigned to the control or intervention group by random draw. If the number of individuals in the intervention and control groups does not reach the required sample size, another comprehensive health service center will be consulted, and this process will be repeated, Blinding description: In this study, a single-blind design means that the statistical analyst is unaware of the group allocation of the participants, which is incorporated to reduce bias in the data analysis process. N/A Type 2 diabetes. Intervention 1: Intervention Group: Content is provided to the research participants via video-sharing websites (Aparat and Namasha) and by sharing session links in virtual groups on social networks (Telegram, Eita, and WhatsApp), involving individuals with type 2 diabetes. This will be implemented in a scheduled manner (every other day, 18 training sessions) for eight weeks for the intervention group, in various multimedia formats, podcasts, educational posters, interactive text, and similar materials. To develop the educational content, the method of literature search, review of the latest evidence, and the opinions of experts in this field will be used. Ultimately, after content production, the content’s validity will be confirmed by reviewing the opinions of 5 experts and 10 patients (with different educational levels and social classes, varying durations and severity of diabetes, and from both genders). The content production method for each of the 18 educational sessions will be approved by at least 2 specialists in the field of e-learning, and an agreement coefficient above 70% will be used for method selection. In cases of disagreement, a third party’s opinion will be consulted. Intervention 2: Control group: The control group will receive only one session per week for five weeks, covering the self-care in diabetes module of the care package, similar to the intervention group. Yes - There is a plan to make this available What will be shared: Raw and final dataset of the clinical trial study When: Access will only be granted upon formal request and with ethics committee approval. To whom: The data and documents related to the study will be accessible exclusively to researchers and members of the scientific community with legitimate research purposes. Access is contingent upon adherence to ethical guidelines, confidentiality agreements, and approval by the ethics committee. Conditions: Data and documents may only be used for legitimate scientific research purposes and must comply with ethical standards. Applicants are required to submit a research proposal and commit to maintaining confidentiality and respecting participants rights. Use of the data is contingent upon approval by the ethics committee and written consent from the study's principal investigators. Where to obtain: The data and documents related to the study will be obtainable from the Shahid Beheshti University of Medical Sciences data repository as well as email at ghadirian.fataneh@gmail.com How to obtain: Applicants must submit a formal request including their research objective, study proposal, and a commitment to confidentiality. The request will be reviewed by the research team and the ethics committee. Upon approval, access will be granted under specific and restricted conditions. Applicants are also required to sign a data use agreement, pledging to use the data solely for the stated purposes. Comments:
public Yasamin Geloumaki Robati
Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaei Heart Hospital, Faculty of Nursing and Midwifery, Intersection of Niayesh Highway (Ayatollah Hashmi Rafsanjani) and Vali Asr (AJ) Street, Tehran
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 gelumaki.Robati98@gmail.com Shahid Beheshti University of Medical Sciences scientific Fataneh Ghadirian Baharanchi
Shahid Beheshti University of Medical Sciences, Faculty of Nursing and Midwifery, in front of Shahid Rajaei Heart Hospital, Intersection of Niayesh Highway (Ayatollah Hashmi Rafsanjani) and Vali Asr (AJ) Street, Tehran
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 ghadirian.fataneh@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Individuals with type 2 diabetes and covered by comprehensive health service centers under the supervision of Shahid Beheshti University of Medical Sciences Have not received any formal psychological or spiritual care or treatments in the past six months. Do not suffer from severe mental illnesses such as psychotic disorders and memory disorders, PTSD diagnosed by a psychiatrist or substance abuse (Based on information from the SIB system and a review of medical history through self-report via telephone contact or a demographic questionnaire). Participants must have been diagnosed with type 2 diabetes or started glucose-lowering medication at least five years prior Have not received diabetes self-management education in the past six months (excluding education provided by comprehensive health service centers or health posts). Having a smartphone Consented to participate in the study 18 years 65 years Both Have severe mental, emotional and psychological disorders such as dementia. At the same time, suffer from debilitating diseases such as cancer, MS, stroke, end stages of liver and kidney diseases, etc. Have vision and hearing problems A pregnant woman with gestational diabetes Have other specific types of diabetes. E11 Type 2 diabetes mellitus Lifestyle Lifestyle Intervention Group: Content is provided to the research participants via video-sharing websites (Aparat and Namasha) and by sharing session links in virtual groups on social networks (Telegram, Eita, and WhatsApp), involving individuals with type 2 diabetes. This will be implemented in a scheduled manner (every other day, 18 training sessions) for eight weeks for the intervention group, in various multimedia formats, podcasts, educational posters, interactive text, and similar materials. To develop the educational content, the method of literature search, review of the latest evidence, and the opinions of experts in this field will be used. Ultimately, after content production, the content’s validity will be confirmed by reviewing the opinions of 5 experts and 10 patients (with different educational levels and social classes, varying durations and severity of diabetes, and from both genders). The content production method for each of the 18 educational sessions will be approved by at least 2 specialists in the field of e-learning, and an agreement coefficient above 70% will be used for method selection. In cases of disagreement, a third party’s opinion will be consulted. Control group: The control group will receive only one session per week for five weeks, covering the self-care in diabetes module of the care package, similar to the intervention group. Self-Efficacy. Timepoint: Before the start of the intervention, immediately after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Diabetes Management Self-Efficacy Scale (DMSES). Self-Care. Timepoint: Before the start of the intervention, immediately after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Self-Care of Diabetes Inventory (SCODI). Health-Related Quality of Life. Timepoint: Before the start of the intervention, immediately after the end of the intervention, 3 months after the end of the intervention. Method of measurement: World Health Organization quality of life questionnaire - Brief version (WHOQoL-BREF). Fasting blood sugar. Timepoint: Twice weekly for eight weeks during the intervention period. Method of measurement: Blood glucose monitoring by patients using a glucometer, and if a glucometer is unavailable, recording the patient’s blood glucose test results during the intervention period (if a test was performed) and record on Blood sugar registration form. Glycosylated hemoglobin (HbA1c). Timepoint: Recording of patients’ HbA1c values from 2024/9/22 to 2024/12/20, if tested. Method of measurement: blood test. Shahid Beheshti University of Medical Sciences Approved 2022-10-02 Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical sciences 13th floor, Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simaye Iran St., between South Flamek and Zarafshan, Quds town (west), Tehran Tehran Tehran Iran (Islamic Republic of)