Protocol summary
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Study aim
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Determining the effect of an integrated psycho-spiritual care package on self-efficacy, self-care and health-related quality of life in adults with type 2 diabetes.
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Design
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a pre-test-post-test, single-blind clinical trial study in which the sample individuals are randomly allocated to two groups: control and intervention.
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Settings and conduct
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Authoritative content development and production, multistage sampling, conducting the first session both in-person and virtually, and completing informed consent forms and questionnaires, followed by 18 virtual training sessions via Eita, Telegram, and WhatsApp, administering post-intervention questionnaires immediately after the intervention and three months later, through virtual means or telephone contact.
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Participants/Inclusion and exclusion criteria
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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.
Absence of severe mental illnesses such as psychotic disorders, memory disorders, PTSD or substance abuse;
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.
Possess the ability to utilize digital technology (mobile phones) and social networks.
Primary exclusion criteria: unwillingness to continue participation in the study, or the occurrence of severe life stressors or unforeseen adverse events.
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Intervention groups
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The intervention group receives the psycho-spiritual care package for 8 weeks, with 18 training sessions, and the control group will receive only 5 sessions of diabetes physical self-care training for 5 weeks.
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Main outcome variables
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Self-Efficacy, Self-Care, Health-Related Quality of Life.
General information
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Reason for update
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Change of supervisor, Change in methodology and change in sampling location.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20221013056164N1
Registration date:
2022-11-15, 1401/08/24
Registration timing:
prospective
Last update:
2025-09-29, 1404/07/07
Update count:
1
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Registration date
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2022-11-15, 1401/08/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-02-20, 1401/12/01
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Expected recruitment end date
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2023-05-22, 1402/03/01
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Actual recruitment start date
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2024-06-22, 1403/04/02
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Actual recruitment end date
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2024-10-09, 1403/07/18
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Trial completion date
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2025-04-25, 1404/02/05
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Scientific title
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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.
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Public title
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Effectiveness of Integrated Psycho-Spiritual Care Package on Self-Efficacy, Self-Care and Health-Related Quality of Life of Adults with Type 2 Diabetes.
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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.
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
118
Actual sample size reached:
58
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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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.
Ethics committees
1
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Ethics committee
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Approval date
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2022-10-02, 1401/07/10
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1401.474
Health conditions studied
1
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Description of health condition studied
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Type 2 diabetes
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ICD-10 code
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E11
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ICD-10 code description
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Type 2 diabetes mellitus
Primary outcomes
1
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Description
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Self-Efficacy
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Timepoint
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Before the start of the intervention, immediately after the end of the intervention, 3 months after the end of the intervention
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Method of measurement
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Diabetes Management Self-Efficacy Scale (DMSES)
2
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Description
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Self-Care
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Timepoint
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Before the start of the intervention, immediately after the end of the intervention, 3 months after the end of the intervention
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Method of measurement
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Self-Care of Diabetes Inventory (SCODI)
3
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Description
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Health-Related Quality of Life
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Timepoint
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Before the start of the intervention, immediately after the end of the intervention, 3 months after the end of the intervention
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Method of measurement
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World Health Organization quality of life questionnaire - Brief version (WHOQoL-BREF)
Secondary outcomes
1
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Description
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fasting blood sugar
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Timepoint
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Twice weekly for eight weeks during the intervention period.
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Method of measurement
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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.
2
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Description
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Glycosylated hemoglobin (HbA1c)
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Timepoint
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Recording of patients’ HbA1c values from 2024/9/22 to 2024/12/20, if tested
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Method of measurement
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blood test
Intervention groups
1
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Description
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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.
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Category
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Lifestyle
2
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Description
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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.
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Raw and final dataset of the clinical trial study
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When the data will become available and for how long
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Access will only be granted upon formal request and with ethics committee approval.
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To whom data/document is available
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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.
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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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.
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Comments
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