The Effectiveness of Using Digital Health and Physical Activity Monitoring Tools on Health Indicators and Treatment Adherence in Older Adults: A Randomized Controlled Study

Investigating the effectiveness of using digital health monitoring tools on improving physical health indicators and medication adherence in the elderly

A randomized, single-blind, parallel-group, controlled clinical trial on 80 individuals over 60 years of age.

This randomized controlled trial enrolls adults ≥60 years attending six Tehran Oil Industry family health centers. Participants are selected through stratified random sampling proportional to each center’s share and gender balance, yielding 80 individuals. Assignment to the intervention (40) and control (40) groups uses stratified-block randomization by an independent statistician with allocation concealment via opaque numbered envelopes. Because the intervention—a digital package with a smartwatch and mobile app—cannot be blinded to participants, only the outcome assessor and statistical analyst are blinded. The 12-week intervention includes training, technical support, and adherence monitoring through weekly reports and motivational calls. Measurements are obtained at baseline and every two weeks using questionnaires, blood pressure/glucometer readings, and wearable-device data, and analyses employ appropriate statistical tests such as paired/independent t-tests, chi-square, and multivariate regression.

People aged 60 and over who visit family health centers and are literate or have a caregiver are included in this plan, and those who do not cooperate or have cognitive impairments are excluded.

In the intervention group, people use a digital watch with a medication reminder app, a pedometer, and a heart rate monitor. The control group receives only usual care.

Fasting blood sugar; medication adherence; satisfaction with technology; use of devices, diastolic and systolic blood pressure.

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.

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.

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.

Up to one year after publication of the article

Reputable researchers at academic institutions

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.

The research manager Dr. Farhad Moradi Shahpar should be emailed. E-mail address: drfmoradi@yahoo.com

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.