NCT04992000

Brief Summary

This study aimed to examine the effects of a public health nursing intervention plus m-Health applications for hypertension management on enhancing the Self-care, systolic and diastolic blood pressure, and quality of life in older adults during the lockdown period in Jordan. Study Hypothesis: There are no differences between the three groups in: H01 HTN self-care (SC-HI) score. H02 Health-related quality of life (SF-36) score. H03 The management of systolic and diastolic BP levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

July 29, 2021

Last Update Submit

August 5, 2021

Conditions

Keywords

self-carehypertensionCOVID-19m-HealthOlder adults

Outcome Measures

Primary Outcomes (2)

  • Self-care (SC-HI) scale

    Self-care of HTN was measured by the SC-HI scale, which developed to measure the self-care in patients with HTN 26. SC-HI has the ability of evaluate the effectiveness of such self-care interventions. SC-HI is 23-item in three subscales: measuring self-care maintenance, monitoring, and management, Cronbach's α were 0.83, 0.75, and 0.83 for the three subscales. For the purpose of this study, authors cross-culturally translated the scale into Arabic in a previous study; Cronbach's α were 0.82, 0.61, and 0.86 for the three subscales 27. . Each subscale is scored distinctly and identical from 0 to 100, the final score calculated as: (the participant score - minimum) / (maximum - minimum) \* 100. The separate score 70 or greater is indicated better self-care.

    basic and after 3 months

  • Changing in systolic and diastolic blood pressure

    Systolic BP (SBP) and diastolic BP (DBP) were measured and recorded by a clinic nurse who has 9 years' experience in the cardiac clinic two times for the purpose of study's analysis; at baseline and after 3 months following the same assessment process: Patients in setting position with their arms at the chest line, relaxed for 5 minutes, then measuring the BP of the right arm using an electronic sphygmomanometer which was checked for calibrated regularly. BP readings through the 3 months were measured by patients themselves at home.

    basic and after 3 months

Secondary Outcomes (1)

  • Quality of life (SF-36) scale

    basic and after 3 months

Study Arms (3)

4-free app + PHN intervention

EXPERIMENTAL

The intervention group was received initial education, 4-free apps, and followed by PHN interventions. Education, app, and PHN intervention

Other: 4-free app + PHN intervention

4-free app alone

EXPERIMENTAL

The apps alone group received the initial education and the 4-free Apps.

Other: 4-free app + PHN intervention

education

NO INTERVENTION

Standard care group received just the initial education.

Interventions

same mentioned in groups

4-free app + PHN intervention4-free app alone

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants were 55 years and above,
  • have follow-up with out-patients of KAUH,
  • had been diagnosed with hypertension,
  • on anti-hypertension medication- at least one drug,
  • reported that he/she has a personal smartphone (Android) - internet access is not important,
  • able to read and understand the Arabic language.

You may not qualify if:

  • Participants have Apple phones,
  • had any psychiatric or mental illness,
  • had a terminal-stage disease or were blind or deaf.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Near east University

Nicosia, Cyprus

Location

Related Publications (1)

  • Alsaqer K, Bebis H. Self-care of hypertension of older adults during COVID-19 lockdown period: a randomized controlled trial. Clin Hypertens. 2022 Jul 15;28(1):21. doi: 10.1186/s40885-022-00204-7.

MeSH Terms

Conditions

HypertensionCOVID-19

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • hatice Bebis, Prof. Dr

    Near East University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 5, 2021

Study Start

June 1, 2020

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

August 12, 2021

Record last verified: 2021-08

Locations