- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05291026
Mobile Health Intervention for Improved Adherence in Type 2 Diabetes
Evaluation of mHealth Intervention to Improve Medication Adherence in Type 2 Diabetes in Nigeria: a Randomized Controlled Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Objectives of the Study: The study assessed patients' glycemic control, knowledge of type 2 diabetes (T2D) and adherence to medications, and evaluated the impact of a mobile telephone-based intervention on these indices.
Study design: Randomized controlled trial Study Setting: Diabetes Clinic, Endocrinology Unit, Department of Internal Medicine, Obafemi Awolowo University Teaching Hospital Ile Ife, Osun State Nigeria The study was structured in five stages. Study Duration: Seven months Stage 1: Baseline data Task 1: Baseline data for patients' glycemic control were obtained from one-year retrospective review of 1392 patients' files for glycated haemoglobin (HbA1c) measurements.
Task 2: Patients' baseline adherence data were obtained from one-year retrospective review of pharmacy refill records (clinic attendance) Task 3: Development and validation of research instruments (Questionnaires, Short Message Services (SMS).
Task 4: Recruitment and training of research assistants (2 hours daily for 3 days) Stage 2: Recruitment and randomization of participants Task 1: Enrolment of all newly-diagnosed patients (n = 120), enrolled in the Diabetes Clinic in the period of one month following Stage 1 Task 2: Obtaining of informed consent from all newly-diagnosed patients enrolled in the Diabetes Clinic in the one month following Stage 1 Task 3: Collection of participants' baseline knowledge data using structured questionnaire Task 4: Collection of baseline self-reported adherence data using the adapted 8-point Morisky Medication Adherence Scale (MMAS-8) instrument Task 5: Randomization of consenting participants into two equal (n = 60) control and intervention groups using a randomization software Stage 3: Intervention Task 1: Activation of short message services to participants in the intervention cohort at a frequency of one message per day for the period of 6 months.
Task 2: Follow up on clinic attendances of all participants for the period of 6 months Stage 4: Post-Intervention Review Task 1: Repeat administration of same questionnaires originally administered at Stage 2 to all participants Task 1: Review of participants' clinic attendance and pharmacy refill records Task 2: Review of participants HbA1c measurements from their records Stage 5: Data analysis Task 1: Demographic variables of participants were analyzed using descriptive statistics including frequency and percentages Task 2: Weighted mean scores were used to analyze knowledge and adherence scores Task 3: Two-sample t-test was used to compare pre- and post-intervention scores of knowledge and adherence Task 4: Chi square test was conducted to analyze associations between demographic variables and self-reported adherence data Task 5: Statistical package for the social sciences (SPSS) version 21 for windows software was used for data analysis at the p < 0.05 level of significance
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Osun
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Ile Ife, Osun, Nigeria, 234
- Obafemi Awolowo University Teaching Hospital Complex
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Diagnosed of type 2 diabetes for the first time in the month following baseline study
- Male or female, 18 yeas of age and above
- Enrolled in the Out-patient Diabetes Clinic of the Teaching Hospital
- Gave informed consent to participate.
Exclusion Criteria:
- Diagnosed of other disease conditions outside type 2 diabetes
- Below 18 years of age
- Not enrolled in the Out-patient Diabetes Clinic of the Teaching Hospital
- Did not give informed consent
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: control group
Type 2 diabetes patients, 18 years old and above, enrolled in the out-patient, diabetes clinic of the tertiary health facility, receiving only standard of care, and who gave their informed consent
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Experimentell: intervention group
type 2 diabetes patients, 18 years old and above, enrolled in the out-patient diabetes clinic of the tertiary health facility, receiving standard of care in addition to a mobile phone - based health education and follow-up messaging on a frequency of once a day corresponding to how often they are expected to take their medications (that is every day), and who gave their informed consent.
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health education and follow-up messaging, randomly assigned to each participant in the intervention arm using a randomization software, delivered once daily, as short message service (sms)
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Primary outcome measure
Tidsram: 6 Months
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Reduction in glycated hemoglobin (HbA1c), measured using blood tests, expressed in mmol/mol (%)
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6 Months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Secondary outcome measure I
Tidsram: 6 months
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Knowledge of diabetes, measured as by the mean score of participants in a questionnaire-based survey
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6 months
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Secondary outcome measure II
Tidsram: 6 months
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Adherence to medication, measured by the mean score of participants in a questionnaire-based survey
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6 months
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Kanayo Osemene, Ph.D., Department of Clinical Pharmacy and Pharmacy Administration, Obafemi Awolowo University, Ile Ife Nigeria
Publikationer och användbara länkar
Allmänna publikationer
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