Stroke AcuteNCT07319312
Evaluating the Effect of Nurse-Led Stroke Transitional Care in Tanzania
An observational study of Stroke Acute and Stroke (CVA) or Transient Ischemic Attack, run by Shandong University at 1 site in Tanzania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Acute, Stroke (CVA) or Transient Ischemic Attack
- What is being tested?
- Nurse-led stroke transitional care program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 130 participants
- Where
- 1 siteTanzania
- Study dates
- 1 Aug 2025to 30 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include nurses, doctors, stroke survivors and caregivers who are directly involved in hospital-to-home transition.
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tanzania1 site, 1 recruiting
- Recruiting
Muhimbili University of Health and Allied Sciences
Dar es Salaam, 65001
Nyagwaswa Michael, Masters, +255685005923, nyagwaswamichael04@gmail.com
Lilian Mselle, PhD, +255717565610, nakutz03@gmail.com
About this study
Official title: 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.
- Being tested
- Nurse-led stroke transitional care program
- Medical subject headings
- Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led stroke transitional care programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Historical control group | Stroke survivors and their caregivers received usual care Receives: Behavioral: Nurse-led stroke transitional care program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 months after discharge
Secondary outcomes (5)
Depression and anxiety among survivors and caregivers
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.
Measured: 6 months after discharge
Care satisfaction among survivors and caregivers
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.
Measured: within 1 month after discharge
Mortality among survivors
This will be counted as a death event after discharge.
Measured: 6 months after discharge
readmission among survivors
This will be measured as number of times the patient is readmitted at the hospital after discharge. High frequency will indicate many readmissions.
Measured: 6 months after discharge
length of hospital stay among survivors
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.
Measured: Day 1 after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Aug 2025
- Primary completion25 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nyagwaswa Athanas Michael, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319312
- Sponsor's protocol ID
- Shandong@2025
- Other IDs
- 72274110
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I will consider sharing it upon finishing enrollment of participants
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Clinical Effectiveness and Implementation Outcomes of Nurse-Led Stroke Transitional Care Model in Tanzania
- ClinicalTrials.gov ID
- NCT07319312
- Acronym / sponsor ID
- Shandong@2025
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 25 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Historical control group | – | Behavioral: Nurse-led stroke transitional care programStroke survivors and their caregivers received usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include nurses, doctors, stroke survivors and caregivers who are directly involved in hospital-to-home transition.
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led stroke transitional care programParticipants 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 | Behavioural | Historical control group |
Primary outcome
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
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
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.
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.
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.
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.
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
5 secondary outcomes
Depression and anxiety among survivors and caregivers
Time frame: 6 months after discharge
Care satisfaction among survivors and caregivers
Time frame: within 1 month after discharge
Mortality among survivors
Time frame: 6 months after discharge
readmission among survivors
Time frame: 6 months after discharge
length of hospital stay among survivors
Time frame: Day 1 after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Undecided. I will consider sharing it upon finishing enrollment of participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Acute and Stroke (CVA) or Transient Ischemic Attack, run by Shandong University at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nyagwaswa Michael, Masters (+255685005923, nyagwaswamichael04@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy among stroke survivors (time frame: 6 months after discharge). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.