NCT07089290

Brief Summary

Despite being the leading cause of cardiovascular diseases and premature death worldwide, hypertension control remains a largely unmet challenge for public health systems even in developed countries. Hypertension control in Nepal is challenging due to decreased awareness, limited access to the health facilities caused by geographical constraints and health care personnel shortage. Telehealth can help address these gaps and nurse-led telehealth can be a better option as nurses can provide timely follow up, track patients' progress and offer guidance on medication adherence and lifestyle changes which are crucial for hypertension control. This study aims to evaluate the effectiveness of nurse-led telehealth for hypertension control among hypertensive adults in Nepal. We will use the Intervention Mapping (IM) approach to develop a theory-based and evidenced nurse-led telehealth intervention for hypertension control. Following IM, a parallel-group 1:1 randomized control trial 353 participants in each group will be used to evaluate the effectiveness of intervention. The intervention consists of regular BP monitoring, video conferencing and virtual drug adjustment. The follow up will be done in 3 and 6 months. Explanatory Sequential mixed Method will be used to assess the acceptability, appropriateness, and feasibility of adapting nurse-led telehealth for hypertension control. Data collection will utilize a self-constructed semi-structured questionnaire, along with validated questionnaires. The collected data will be analyzed using STATA 14, contributing valuable insights into the potential impact of nurse-led telehealth interventions on increasing hypertension control.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
706

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress79%
Nov 2025Jun 2026

First Submitted

Initial submission to the registry

July 14, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

8 months

First QC Date

July 14, 2025

Last Update Submit

July 21, 2025

Conditions

Hypertension Combined Diastolic and Systolic

Outcome Measures

Primary Outcomes (1)

  • Change in Systolic Blood Pressure

    It is the difference in Systolic Blood Pressure from the endline to baseline measured in mmHg.

    6 months

Secondary Outcomes (4)

  • Change in Diastolic Blood pressure

    6 months

  • Blood pressure control

    6 months

  • Medication Adherence

    6 months

  • Hypertension selfcare

    6 months

Study Arms (2)

Standard Care

ACTIVE COMPARATOR
Behavioral: Nurse-led Telehealth Intervention

Nurse-led Telehalth Intervention

EXPERIMENTAL
Behavioral: Nurse-led Telehealth Intervention

Interventions

Nurse-led Telehealth InterventionBEHAVIORAL

Control group: Patients will receive standard care as per Nepal government guidelines. This includes lifestyle counseling (salt reduction, physical activity, avoiding tobacco/alcohol), antihypertensive medications based on BP and risk profile, and follow-up every 1-3 months. BP will be recorded at 3 and 6 months by research nurses. Intervention group: Nurse-led telehealth care will be delivered over six months using the Intervention Mapping approach. Participants will receive initial orientation, a BP diary, and instructions to check BP at least twice weekly at nearby centers. Nurses will train local staff, and conduct teleconsultations via Viber/WhatsApp every 15 days (months 1-2) and monthly (months 3-6) covering BP review, adherence, and lifestyle advice. If \<75% of BP readings meet target, nurses will consult physicians for medication adjustments. Emergency protocols will be in place. Data will be collected at baseline, 3, and 6 months.

Nurse-led Telehalth InterventionStandard Care

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 30 years and above
  • Blood pressure at baseline of more than 140 or 90 mm Hg on at least two separate visits or under antihypertensive medications
  • Willing to monitor their blood pressure and self-titrate medication
  • Possess a smartphone with internet access and WhatsApp/Viber at least biweekly
  • No cognitive deficit and able to communicate effectively to carry out study tasks
  • Not planning to change residence during the 6-month follow-up

You may not qualify if:

  • Pregnant women
  • Patients in hypertensive crisis (BP ≥180/120 mm Hg)
  • Had a stroke in the past 30 days or are on dialysis
  • Individuals with self-reported serious advanced illness such as terminal cancer
  • Patients enrolled in other BP research during the same period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kathmandu University School of Medical Sciences

Dhulikhel, Bagmati, 44600, Nepal

Location

Related Publications (3)

  • Bulto LN, Roseleur J, Noonan S, Pinero de Plaza MA, Champion S, Dafny HA, Pearson V, Nesbitt K, Gebremichael LG, Beleigoli A, Gulyani A, Schultz T, Hines S, Clark RA, Hendriks JM. Effectiveness of nurse-led interventions versus usual care to manage hypertension and lifestyle behaviour: a systematic review and meta-analysis. Eur J Cardiovasc Nurs. 2024 Jan 12;23(1):21-32. doi: 10.1093/eurjcn/zvad040.

    PMID: 37130339BACKGROUND

  • Omboni S, McManus RJ, Bosworth HB, Chappell LC, Green BB, Kario K, Logan AG, Magid DJ, Mckinstry B, Margolis KL, Parati G, Wakefield BJ. Evidence and Recommendations on the Use of Telemedicine for the Management of Arterial Hypertension: An International Expert Position Paper. Hypertension. 2020 Nov;76(5):1368-1383. doi: 10.1161/HYPERTENSIONAHA.120.15873. Epub 2020 Sep 14.

    PMID: 32921195BACKGROUND

  • McManus RJ, Little P, Stuart B, Morton K, Raftery J, Kelly J, Bradbury K, Zhang J, Zhu S, Murray E, May CR, Mair FS, Michie S, Smith P, Band R, Ogburn E, Allen J, Rice C, Nuttall J, Williams B, Yardley L; HOME BP investigators. Home and Online Management and Evaluation of Blood Pressure (HOME BP) using a digital intervention in poorly controlled hypertension: randomised controlled trial. BMJ. 2021 Jan 19;372:m4858. doi: 10.1136/bmj.m4858.

    PMID: 33468518BACKGROUND

Related Links

MeSH Terms

Conditions

Systolic Murmurs

Condition Hierarchy (Ancestors)

Heart MurmursSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Archana Shrestha, PhD

    Kathmandu University School of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bhawana Regmi, MSN

CONTACT

9779849028555bhawanaregmi@kusms.edu.np

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 14, 2025

First Posted

July 28, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

NE(1)