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IRCT20220314054282N1 IRCT 2022-12-19 Shahid Beheshti University of Medical Sciences comprehensive empowerment program in older patients with diabetes The effect of comprehensive empowerment program on age-related outcomes in older patients with diabetes 2023-01-21 anticipated 80 Complete https://irct.ir/trial/67245 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Subjects will be randomly assigned to the intervention and control groups by blocking; selecting subjects will be from person to person. For allocation concealment, each control and intervention group will be given a letter (A and B), and blocks will be put into the non-transparent envelopes after production; then, the first subject will be asked to pick an envelope; the first letter will demonstrate the group of the mentioned subject and the other letters in this block will show the order of following subjects. After finishing this block, the next subject will be asked to pick an envelope, and the assignment will be implemented in this manner till the sampling is completed, Blinding description: the information given to the analyser will be in codes which compliment the classification to the intervention and control groups and the subjects themselves. N/A Condition 1: Being diagnosed of diabetes type 2 for at least one year. Condition 2: Being 65 years old and more. Condition 3: Mark 5 or more in constipation assessment scale. Intervention 1: Intervention group: will comprehensive empowerment program besides routine care. The comprehensive empowerment program will be implemented in the physical aspect (introduction to the disease, monitoring the signs and symptoms, constipation management, and the importance of therapeutic adherence), psycho-social aspect (stress management and relaxation methods), and spiritual aspect (promotion of hope and focusing on the strengths and recommendation of coping strategies and personal meaning of the subject in life). The empowerment sessions will be in-person, 30 to 60 minutes (as needed), in groups of a few. They will be held in an environment with suitable ventilation and considering health protocols. The number of sessions and the context will be determined, edited, and validated under the suggestion of consultants who are specialists in the mentioned aspects and empowerment. Participants will be followed up by means of a phone call between sessions to be answered if there is any question or ambiguity. The presence of a key family caregiver will be necessary for some sessions so the family caregiver will be asked if there is any question or ambiguity. Intervention 2: Control group: will receive routine care. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Not decided yet
public Marzieh Pazokian
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Niyayesh Complex, Niyayesh Cross-Section, ValiAsr St, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5372 Pazokian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Marzieh Pazokian
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Niyayesh Complex, Niyayesh Cross-Section, ValiAsr St, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5372 pazokian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Being diagnosed of diabetes for at least one year. Being able to speak Farsi. Being 65 years old and more Mark 5 or more in constipation assessment scale The older adult or his/her key caregiver has access and ability to use electronic devices for connecting to the web, watching video and reading text. 65 years no limit Both Affliction of covid-19 during the in-person sessions, mental health or cognitive disorders Participation in similar empowerment programs Being in the acute and emergency conditions like keto-acidosis, and life-threatening hyperglycemic attacks Not being able to continue the participation (death, intensive care needs, immigrations) Not participating in all sessions or even alternative/compensatory sessions E08 K59.0 Diabetes mellitus due to underlying condition Constipation Other Other Intervention group: will comprehensive empowerment program besides routine care. The comprehensive empowerment program will be implemented in the physical aspect (introduction to the disease, monitoring the signs and symptoms, constipation management, and the importance of therapeutic adherence), psycho-social aspect (stress management and relaxation methods), and spiritual aspect (promotion of hope and focusing on the strengths and recommendation of coping strategies and personal meaning of the subject in life). The empowerment sessions will be in-person, 30 to 60 minutes (as needed), in groups of a few. They will be held in an environment with suitable ventilation and considering health protocols. The number of sessions and the context will be determined, edited, and validated under the suggestion of consultants who are specialists in the mentioned aspects and empowerment. Participants will be followed up by means of a phone call between sessions to be answered if there is any question or ambiguity. The presence of a key family caregiver will be necessary for some sessions so the family caregiver will be asked if there is any question or ambiguity. Control group: will receive routine care. Glycemic control. Timepoint: At first and then 3 months later. Method of measurement: Will be determined by draining 2-3 cc blood and measuring glycosylated hemoglobin at first and then 3 months later. Constipation. Timepoint: Measuring at the beginning, one month after starting the study and 3 months after starting the study. Method of measurement: Utilizing constipation assessment scale. Polypharmacy. Timepoint: Measuring at the beginning, one month after starting the study and 3 months after starting the study. Method of measurement: Utilizing Screening Tool of Older persons' potentially inappropriate prescriptions (STOPP) Version 2. Active aging. Timepoint: Measuring at the beginning, one month after starting the study and 3 months after starting the study. Method of measurement: Active Aging Measurement Instrument. Health costs. Timepoint: Measuring at the beginning, one month after starting the study and 3 months after starting the study. Method of measurement: Researcher-made questionnaire. Blood pressure. Timepoint: Measuring at the beginning, one month after starting the study and 3 months after starting the study. Method of measurement: Using manual blood pressure measurement instrument under TRUE consortium standards. Shahid Beheshti University of Medical Sciences Approved 2022-10-25 Research Ethics Committee of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)