Determining the effect of comprehensive empowerment program on age-related outcomes in older patients with diabetes.
Design
A clinical trial, single-blinded, with a control group, of 40 participants in each group, blocking will be implemented for randomization.
Settings and conduct
The research environment consists of medical and endocrinology wards and endocrinology and metabolic clinics in educational and medical centers affiliated with Shahid Beheshti University of Medical Sciences and other centers and forums out of the mentioned settings. After introducing the researcher, and the aim of the study to the eligible participants and taking informed consent from them in the research environment, available sampling will be implemented. After selection, they will be randomly divided into intervention and control groups.
The Analyser will be blinded to the control and intervention group by giving unidentified codes to each control and intervention group.
Participants/Inclusion and exclusion criteria
Being diagnosed of diabetes for at least one year.
Being able to speak Farsi.
Being 65 years old and more
Mark 5 or more on the constipation assessment scale
The older adult or his/her crucial caregiver can access and use electronic devices to connect to the web, watch videos and read text.
Intervention groups
The intervention group will receive the empowerment program which consists of the physical aspect (knowing about the disease, monitoring signs and symptoms, constipation management, and the importance of compliance to the therapy), psycho-social aspect (stress management and relaxation methods), and spiritual aspect.
Main outcome variables
Constipation; blood pressure; glycosylated hemoglobin; active aging; poly-pharmacy; health costs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220314054282N1
Registration date:2022-12-19, 1401/09/28
Registration timing:prospective
Last update:2022-12-19, 1401/09/28
Update count:0
Registration date
2022-12-19, 1401/09/28
Registrant information
Name
Amin Mohammadi Nochaman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3264 0707
Email address
aminmohammadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of comprehensive empowerment program on age-related outcomes in older patients with diabetes
Public title
comprehensive empowerment program in older patients with diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University
Street address
Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-10-25, 1401/08/03
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.162
Health conditions studied
1
Description of health condition studied
Being diagnosed of diabetes type 2 for at least one year.
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
2
Description of health condition studied
Being 65 years old and more
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Mark 5 or more in constipation assessment scale
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
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.
2
Description
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
3
Description
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
4
Description
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
5
Description
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
6
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Other
2
Description
Control group: will receive routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Mohammad Reza Haji Esmaeili
Street address
Southern Kargar Ave., Lashgar inter-section, Makhsoos St. Tehran.