Evaluating the Effect of Nurse-Led Stroke Transitional Care in Tanzania

December 21, 2025 updated by: Nyagwaswa Athanas Michael, Shandong University

Evaluating the Clinical Effectiveness and Implementation Outcomes of Nurse-Led Stroke Transitional Care Model in Tanzania

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Tanzania
      • Dar es Salaam, Tanzania, 65001
        • Recruiting
        • Muhimbili University of Health and Allied Sciences
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nyagwaswa Michael, masters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion criteria

  • 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,
  • Stroke survivors who are expected to survive for 3 months
  • Family caregivers with mobile phones
  • Family caregivers who can read and write
  • Family caregivers who are able to communicate
  • Family caregivers who live with the patient after stroke

Exclusion criteria

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Historical control group
Stroke survivors and their caregivers received usual care
Behavioral: Nurse-led stroke transitional care program
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-efficacy among stroke survivors
Time Frame: 6 months after discharge
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
Time Frame: 6 months after discharge
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
Time Frame: within 1 month after discharge
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
Time Frame: within 1 month after discharge
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
Time Frame: 6 months after discharge
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
Time Frame: within 1 month after discharge
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
Time Frame: 6 months after discharge
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depression and anxiety among survivors and caregivers
Time Frame: 6 months after discharge
Depression and anxiety that will be measured by the locally validated 10-items Kessler Psychological Distress Scale with a=0.85. This will be measured by a scale as total scores and mean scores. High total and mean scores indicate poor mental health status after discharge.
6 months after discharge
Care satisfaction among survivors and caregivers
Time Frame: within 1 month after discharge
Satisfaction of hospital care will be measured by a questionnaire developed specific for this study. It will be measured as total scores and mean scores. High total and mean scores indicate good satisfaction with transitional care.
within 1 month after discharge
Mortality among survivors
Time Frame: 6 months after discharge
This will be counted as a death event after discharge.
6 months after discharge
readmission among survivors
Time Frame: 6 months after discharge
This will be measured as number of times the patient is readmitted at the hospital after discharge. High frequency will indicate many readmissions.
6 months after discharge
length of hospital stay among survivors
Time Frame: Day 1 after discharge
This will be measured as number of days spent in the hospital before discharge. This will be calculated as number of days spent at the hospital from admission to discharge. High number above 5 indicates long hospital stay.
Day 1 after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Shandong@2025
  • 72274110 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

I will consider sharing it upon finishing enrollment of participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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