NCT07319312

Brief Summary

The goal of this observational study is to assess the effects of nurse-led stroke transitional care in stroke survivors, caregivers and healthcare providers who participate in nurse-led stroke transitional care program to improve discharge preparedness, disease self-management and quality of life among stroke survivors. The main question it aims to answer is: does nurse-led stroke transitional care program improve discharge preparedness, disease self-management and quality of life among stroke survivors? Participants are currently participating in nurse-led stroke transitional care program as part of their medical care. Stroke survivors and their caregivers will be followed for six months period to assess their transitional care quality and clinical outcome measures.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

November 19, 2025

Last Update Submit

December 21, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • Self-efficacy among stroke survivors

    Ability to take control and perform recommended health behaviors and discharge instructions. Self-efficacy will be measured by the Stroke Self-Efficacy Questionnaire (a=0.9) developed by Jones and colleagues. This will be measured by a scale as total scores and mean scores. High total and mean scores indicate better ability to follow and adhere to healthy lifestyles after stroke

    6 months after discharge

  • Quality of life among stroke survivors

    Quality of life that will be measured by the Stroke Specific Quality of Life (SSQoL) with (a=0.85). This will be measured by a scale as total scores and mean scores. High total and mean scores indicate better quality of life as evidenced by ability to perform self-care activities, improved cognitive function, mobility, and engaging in social activities

    6 months after discharge

  • Discharge preparedness among survivors

    Discharge preparedness that will be measured by the Short Forms of the Readiness for Hospital Discharge Scale (RHDS) developed by Weiss. This will be measured by a scale as total scores and mean scores. High total and mean scores indicate readiness for hospital-to-home discharge among stroke survivors.

    within 1 month after discharge

  • Discharge preparedness among health care providers

    Discharge preparedness that will be measured by the Short Forms of the Readiness for Hospital Discharge Scale (RHDS) developed by Weiss. This will be measured by a scale as total scores and mean scores. High total and mean scores indicate agreement on readiness for hospital-to-home discharge among nurses and doctors.

    within 1 month after discharge

  • Resilience among caregivers

    Resilience will be measured by the 10-items Connor-Davidson Resilience Scale (CD-RISC) validated by Laura with a=0.85). This will be measured by a scale as total scores and mean scores. High total and mean scores indicate better ability and readiness to take care giving responsibilities.

    6 months after discharge

  • Quality of transition care among survivors and caregivers

    Quality of TC will be measured by the Care Transitions Measure (CTM) Tool developed by Eric Coleman. This will be measured by a scale as total scores and mean scores. High total and mean scores indicate better perceived quality of transition care.

    within 1 month after discharge

  • Caregiver self-efficacy

    Caregiver self-efficacy will be measured by the 10-items Family Caregiver Activation Tool (FCAT) developed by Coleman with a=0.6. This will be measured by a scale as total scores and mean scores. High total and mean scores indicate better ability to assist the stroke survivors to follow and adhere to healthy lifestyles and clinic appointment after stroke

    6 months after discharge

Secondary Outcomes (5)

  • Depression and anxiety among survivors and caregivers

    6 months after discharge

  • Care satisfaction among survivors and caregivers

    within 1 month after discharge

  • Mortality among survivors

    6 months after discharge

  • readmission among survivors

    6 months after discharge

  • length of hospital stay among survivors

    Day 1 after discharge

Study Arms (1)

Historical control group

Stroke survivors and their caregivers received usual care

Behavioral: Nurse-led stroke transitional care program

Interventions

Participants in intervention group will receive usual care plus nurse-led stroke transitional care. Two nurse champions will conduct the face-to-face sessions while other two nurse researchers will conduct the telephone call sessions between August and December, 2025. During hospitalization, the two nurse champions will conduct five face-to-face sessions (2 individual sessions at admission; and at discharge), and three group sessions with 2-4 dyads of patients and caregivers. After hospitalization, two nurse researchers will conduct seven follow-up sessions for three months via phone calls at day 3, week 1, week 3, week 5, week 7, week 9, and week 11. The face-to-face sessions and phone call sessions will take 40-60 minutes and 20-30 minutes respectively

Historical control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include nurses, doctors, stroke survivors and caregivers who are directly involved in hospital-to-home transition.

You may qualify if:

  • Clinical nurses and physicians with six months of working experience in stroke care
  • Clinical nurses and physicians with a minimum of diploma in their professions.
  • Stroke survivors with 18 years old and above
  • Stroke survivors admitted in the stroke units
  • Stroke survivors with primary diagnosis of stroke confirmed by brain CT/MRI
  • Stroke survivors who undergo usual discharge process
  • Stroke survivors who live with their family caregivers
  • Stroke survivors who have mobile phones
  • Stroke survivors who can read and write
  • Stroke survivors who are able to communicate
  • Stroke survivors with National Institutes of Health Stroke Scale (NIHSS) \< 6
  • Stroke survivors with Modified Barthel Index (MBI) \> 9
  • Stroke survivors with Modified Rankin Scale (mRS) \< 5
  • Stroke survivors with Montreal Cognitive Assessment Test (MoCA) \> 14
  • Stroke survivors who are expected to stay in the ward for 3-5 days,
  • +5 more criteria

You may not qualify if:

  • Healthcare providers who will be on leave during the study period.
  • Stroke survivors with previous stroke who are not admitted in stroke units
  • Stroke survivors who are discharged against medical advice
  • Stroke survivors who have end-stage organ failure
  • Stroke survivors who have family caregivers
  • Stroke survivors who can't read/write
  • Stroke survivors who have no mobile phones.
  • Family caregivers without mobile phone that is accessible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, 65001, Tanzania

RECRUITING

MeSH Terms

Conditions

StrokeIschemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Central Study Contacts

Nyagwaswa Michael, Masters

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 19, 2025

First Posted

January 6, 2026

Study Start

August 1, 2025

Primary Completion

March 25, 2026

Study Completion

March 30, 2026

Last Updated

January 6, 2026

Record last verified: 2025-12

Locations