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IRCT20251102067858N2 IRCT 2025-12-09 Tehran University of Medical Sciences The effectiveness of digital tools in improving the health of the elderly The Effectiveness of Using Digital Health and Physical Activity Monitoring Tools on Health Indicators and Treatment Adherence in Older Adults: A Randomized Controlled Study 2025-12-22 anticipated 80 Complete https://irct.ir/trial/87678 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling method Sampling of elderly people ≥60 years old is done by stratified random sampling from six family health centers of Tehran Oil Industry. Each center has a quota proportional to the population covered and gender distribution (50% female, 50% male) is maintained in the initial selection process. Random allocation method Eligible participants enter the study after written consent. The method of allocation of participants to groups is based on "stratified block randomization"; in this way, according to the combination of "health center × gender", twelve layers are formed and in each layer, variable blocks of 4 and 6 people are used to prevent predictability of the sequence. The allocation ratio in all layers is 1:1 so that in the end, each group consists of 40 people (20 women and 20 men) with complete gender balance. Random sequences are generated by an independent statistician using Random Allocation Software. To conceal the allocation, opaque, sealed, and numbered envelopes are used, and the researcher responsible for registration will be unaware of the allocation sequence until the envelope is opened, Blinding description: Due to the nature of the intervention, blinding of participants is not possible, but the outcome assessor and statistical analyst will be blinded to the type of intervention. The master sequence file will be kept by an independent statistician, and a full description of the randomization method will be recorded and documented in an appendix to the protocol. N/A Condition 1: Hypertension. Condition 2: Diabetes. Intervention 1: The intervention includes a “digital elderly monitoring package” consisting of a TCHZ10 smartwatch capable of measuring steps, hourly activity, heart rate, and data transmission to a dedicated study app; the app is activated with a participant-specific user account, daily status dashboard, educational messages, and the ability to automatically send data to a secure research server. The intervention will be implemented for 12 weeks, and participants are required to use the device for at least 10 hours per day. At the beginning, a 30- to 45-minute in-person session will be held at the center for installation, instruction in use, and brochure presentation, and telephone support will be provided for technical issues and reporting of potential complications throughout the study. Adherence will be monitored by receiving weekly reports of usage hours and key indicators, and in the event of decreased adherence, motivational calls and troubleshooting guidance will be made. The control group will receive the center’s usual care without any digital tools. All device settings, app version, and educational instructions are fully documented in the protocol’s technical appendix, allowing for accurate replication of the intervention. Intervention 2: Control group: The control group only receives the usual care provided in family health centers, namely examination, prescription of medication and diagnostic procedures, drug counseling, and specialist referral if necessary. Yes - There is a plan to make this available What will be shared: If requested by the researchers, after observing ethical and legal considerations, all data will be made available exclusively to the researcher in the form of an Excel or SPSS file in order to advance knowledge, without mentioning the names and characteristics of the subjects. When: Up to one year after publication of the article To whom: Reputable researchers at academic institutions Conditions: For use in subsequent research, which must be approved by the research ethics committee of a university or an accredited scientific center. This request is subject to approval by the Research Council of the Sports Medicine Research Center. Therefore, the subsequent analysis of the data must be based on research ethics and contribute to the advancement of knowledge. Where to obtain: The research manager Dr. Farhad Moradi Shahpar should be emailed. E-mail address: drfmoradi@yahoo.com How to obtain: After receiving the request from the Research Council of the Research Center, the research plan is prepared and, if approved, the desired information is made available to the researcher, in compliance with legal requirements. Comments:
public Farhad Moradi Shahpar
Sports Medicine Research Center, No 7, Ahmadi Street, Jalal-e-Al-e-Ahmad Highway
Tehran Iran (Islamic Republic of) 141734143 +98 21 8863 0228 f_moradishahpar@sbu.ac.ir Tehran University of Medical Sciences scientific Farhad Moradi Shahpar
Sports Medicine Research Center, No 7, Ahmadi Street, Jalal-e-Al-e-Ahmad Highway
Tehran Iran (Islamic Republic of) 1411734143 +98 21 8863 0228 f_moradishahpar@sbu.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Elderly people over 60 years of age visiting family health centers Being literate or having a home caregiver 60 years no limit Both Non-cooperation Severe cognitive problems I10 E08 Essential (primary) hypertension Diabetes mellitus due to underlying condition Prevention Prevention The intervention includes a “digital elderly monitoring package” consisting of a TCHZ10 smartwatch capable of measuring steps, hourly activity, heart rate, and data transmission to a dedicated study app; the app is activated with a participant-specific user account, daily status dashboard, educational messages, and the ability to automatically send data to a secure research server. The intervention will be implemented for 12 weeks, and participants are required to use the device for at least 10 hours per day. At the beginning, a 30- to 45-minute in-person session will be held at the center for installation, instruction in use, and brochure presentation, and telephone support will be provided for technical issues and reporting of potential complications throughout the study. Adherence will be monitored by receiving weekly reports of usage hours and key indicators, and in the event of decreased adherence, motivational calls and troubleshooting guidance will be made. The control group will receive the center’s usual care without any digital tools. All device settings, app version, and educational instructions are fully documented in the protocol’s technical appendix, allowing for accurate replication of the intervention. Control group: The control group only receives the usual care provided in family health centers, namely examination, prescription of medication and diagnostic procedures, drug counseling, and specialist referral if necessary. Using tools. Timepoint: At the beginning of the study and 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks after the start of the intervention (use of the bracelet/smartwatch). Method of measurement: Questionnaire (yes/no). Fasting Blood Sugar. Timepoint: At the beginning of the study and 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks after the start of the intervention (use of the bracelet/smartwatch). Method of measurement: Glucometer. Systolic and diastolic blood pressure. Timepoint: At the beginning of the study and 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks after the start of the intervention (use of the bracelet/smartwatch). Method of measurement: Digital blood pressure monitor. Medication adherence. Timepoint: At the beginning of the study and 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks after the start of the intervention (use of the bracelet/smartwatch). Method of measurement: Score from the MMAS-8 questionnaire. Satisfaction with technology. Timepoint: At the beginning of the study and 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks after the start of the intervention (use of the bracelet/smartwatch). Method of measurement: Average scores on the TAM (Technology Acceptance Model) questionnaire. Tehran University of Medical Sciences Approved 2025-07-13 Ethics committee of Tehran University of Medical Sceinces 6th floor, Headquarters of Tehran University of Medical Sceinces, Corner of Qods St. Kehsavarz Blvd Tehran Tehran Iran (Islamic Republic of)