Effectiveness of Phone Call and Video-based Interventions to Improve Adherence to Medications in Hypertensive Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Ghana
About this trial
The goal of this clinical trial is to find out if phone call and video-based interventions that seek to educate people with uncontrolled high blood pressure and also remind them to take their medicines will improve adherence to their medicines. It will also examine if the interventions are economical to implement. The main objectives of the study are:
* Design videos and phone call-based interventions for people with hypertension. * Examine the effect of videos and phone call-based intervention on adherence to medication in people with hypertension. * Calculate the costs associated with the mobile health intervention * Examine the factors influencing acceptance of video and phone calls based interventions for improving adherence to antihypertensive medications among patients
Participants will:
* Receive the intervention thrice weekly for 3 months * Visit the health facility at the end of 3 months for check up and measurement of outcome variables (adherence and blood pressure). Additionally, at the end of 3 months, the acceptability of the interventions will be measured among the participants who received either phone call or video.
Researchers will compare the two groups (one group will utilize phone call whereas the other videos) with the control group to see if the mobile interventions improve adherence to medicines. Only adults 18 years and above in selected health facilities in the Eastern will participate in the study. The selected participants should have uncontrolled blood pressure based on readings from last 2 visits. To be included in the study, the participants need to own a smartphone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult aged 18 years or older
diagnosed of hypertension
has uncontrolled hypertension (i.e. systolic blood pressure ≥140 mmHg and a diastolic blood pressure ≥ 90mmHg) documented in their records on 2 clinic visits
has been prescribed at least one antihypertensive medication for a period of 2 months before the study
Disqualifiers
Pregnant women with hypertension or within 3 months postpartum
Hypertensive patients with diabetes, liver failure or kidney disease
Plans to travel out of the country during the period of the study
Participating in another mobile health intervention or medication adherence intervention
Trial design
Design model
Parallel
Treatments tested in this trial
phone call based intervention
Other interventionThe phone call based intervention seek to educate patients about hypertension and the medications used. It also seeks to remind patients to take their medications. This will be done thrice weekly
Video based intervention
Other interventionThe video based intervention seek to educate patients about hypertension and the medications used. It also seeks to remind patients to take their medications. This will be done thrice weekly
Usual Care
Other interventionThe usual care concerns the care the participants receive from the health facility. Participants in this group would neither receive the phonecall or video based interventions.
Treatment groups
1,400 Participants
are divided into 3 treatment groupsGroup A: the video-groupActive comparator 1 intervention
Group B: the phone call groupActive comparator 1 intervention
Group C: control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
change in systolic blood pressure
The systolic blood pressure at baseline will be compared to the systolic pressure at endline. This will help to determine if the intervention has an effect on the blood pressure
Time frame
baseline and 3 months2
Medication adherence measured using the Morisky Medication Adherence Scale-8(MMAS-8)
Medication adherence will be measured at baseline and then after administering the intervention. MMAS-8 has eight items on the scale. The first seven (7) items on the scale require a yes or no response whereas the eighth item uses a five-point Likert scale (never/rarely to all the time). The total score ranges from 0 to 8 with a score of \<6 indicative of non-adherence. A score between 6 \< 8 indicates medium adherence whereas a score of 8 shows high adherence.
Time frame
baseline and 3 monthsSecondary outcomes
1
Proportion of patients with controlled blood pressure
The proportion of patients with controlled blood pressure after administration of the intervention would be measured
Time frame
baseline and 3 months2
Acceptability of the intervention
Participants in the intervention groups will answer questions on the acceptability of the interventions received at the end of the study i.e after the interventions have administered. The instrument that will be used is based on the Unified Theory of Acceptance and Use of Technology which has 5 -Likert scale. Higher scores indicates acceptability of the intervention.
Time frame
3 monthsLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
St Joseph Catholic HospitalRecruiting Efiduase, Koforidua
Ghana
GhanaSponsors and contacts
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Source ClinicalTrials.gov