StrokeNCT04337034
F@ce 2.0 a Mobile Phone-supported and Family-centred Rehabilitation Intervention After Stroke in Uganda
A study testing Mobile phone supported and family-centred rehabilitation and Information and blood pressure measurement in people with Stroke, run by Karolinska Institutet at 3 sites in Uganda.
Trial summary
The purpose of the present proposal is to implement and evaluate a new model for mobile phone supported and family-centred rehabilitation intervention (F@ce 2.0) with regard to functioning in activities in daily living and participation in everyday life among persons with stroke and their families (in rural and urban… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Mobile phone supported and family-centred rehabilitation and Information and blood pressure measurement
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 3 sitesUganda
- Study dates
- 16 Jun 2022to 10 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- stroke diagnosis identified with CT scan or clinical symptoms
- inhabitant in a rural part of Kalungu District, near Masaka Uganda, or Kampala with surroundings
- access to and ability to use a mobile phone
- ability to speak and express themselves in English and/or Luganda
- Modified Rankin Scale level 2 to 4.
Who cannot join
- none
Trial locations and contacts
3 sites in 1 country.
Uganda3 sites
Mulago Hospital
Kampala
Stroke Rehabilitation Centre
Kampala
Masaka Hospital
Masaka
About this study
Official title: Participation in Everyday Life - A Randomized Controlled Trial of Mobile Phone-supported and Family-centred Rehabilitation After Stroke in Uganda.
The purpose of the present proposal is to implement and evaluate a new model for mobile phone supported and family-centred rehabilitation intervention (F@ce 2.0) with regard to functioning in activities in daily living and participation in everyday life among persons with stroke and their families (in rural and urban areas) in Uganda.
Read the detailed description
The investigators' previous feasibility study suggested beneficial effects on self-efficacy and occupational performance and satisfaction of a mobile phone supported and family-centred rehabilitation intervention (F@ce1.0) after stroke in Uganda. The purpose of the present proposal is to implement and evaluate F@ce on functioning in activities in daily living (ADL) and participation in everyday life among persons with stroke and their families.
With recommendations on evaluation of complex interventions both outcomes and processes will be studied and hence both quantitative and qualitative methods will be applied. In a randomized controlled trial F@ce 2.0 will be evaluated compared to ordinary rehabilitation in urban/rural Uganda regarding; self-efficacy, perceived performance and participation in everyday activities, independence in ADL, health care utilization and the families´ perceived participation in everyday activities. Qualitative data will explore experiences of people with stroke and family members of participating in F@ce 2.0. This research program has a multidisciplinary perspective for sustainable rehabilitation, a prerequisite for better living conditions for people with stroke in low/middle income countries.
- Conditions
- Stroke
- Being tested
- Mobile phone supported and family-centred rehabilitation, Information and blood pressure measurement
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone supported and family-centred rehabilitationBehavioural
Participants in the intervention group will receive an eight-week mobile phone supported and family-centred rehabilitation intervention (F@ce 2.0).The participants will be introduced to a problem-solving strategy intended to facilitate the learning and problem-solving process to be used during the intervention. The strategy will provide a structure for healthcare professionals delivering the intervention. Three targets (goals) in daily activities will be formulated that the person wants and needs to do within the home environment. Each activity will be practiced together with the healthcare professionals and family members. Family members will be informed about the participant's target activities and the planned strategies for reaching the targets. The participants will practice the target activities in their home environment supported by mobile phone calls and SMS. In addition they will be given information about stroke and their blood pressure will be measured.
Information and blood pressure measurementProcedure or surgery
Control group participants will be given information about stroke and their blood pressure will be measured.
| Study group | Role | What they receive |
|---|---|---|
| mobile phone supported and family-centred rehabilitation | Experimental | Participants in the intervention group will receive an 8-week mobile phone supported and family-centred rehabilitation intervention (F@ce 2.0) Receives: Behavioral: Mobile phone supported and family-centred rehabilitation; Procedure: Information and blood pressure measurement |
| Information and blood pressure measurement | Active comparator | Control group participants will be given information about stroke and their blood pressure will be measured Receives: Procedure: Information and blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy Scale
Participants are instructed to rate how confident they feel about performing each of 16 everyday activities on a 10-point rating scale ranging from 1) "not confident at all in my ability" to 10) "very confident in my ability". The average of all responses are calculated.
Measured: Differences in change between baseline and 3, 6 and 12 months
Secondary outcomes (3)
Canadian Occupational Performance Measure (COPM)
COPM measures performance and satisfaction in self-care, productivity and leisure from the individual's perspective using a scale of 1-10. The participant is asked 1) to rate performance of the specified activities using a 1 to 10 scale and 2) to score his or her satisfaction with that performance using the same scale. Weighted scores of the chosen activities are added separately for performance and satisfaction to create two summative scores. The summative scores are then divided by the number of rated activities to provide COPM scores.
Measured: Differences in change between baseline and 3, 6 and 12 months
Stroke Impact Scale (SIS) 3.0 Uganda version
Assesses the perceived impact on functioning in everyday life in eight domains: Strength, Memory and thinking, Emotions, Communication, ADL/ Instrumental activities of daily living (IADL), Mobility, Hand function and Participation. The SIS includes 59 items within these eight domains. Aggregated scores ranges from 0 to 100, the higher the score, the lower the perceived impact of stroke, i.e. fewer problems in everyday life. The SIS 3.0 also includes a question to assess the participant's global perception of recovery presented in a vertical analogue scale ranging from '0 = no recovery to 100 = full recovery'.
Measured: Differences in change between baseline and 3, 6 and 12 months
Barthel Index
Measures independence in 10 self-care and mobility activities. Scores range from 0 to 100, with a lower score indicating greater dependency.
Measured: Differences in change between baseline and 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start16 Jun 2022
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to participate in F@ce 2.0 (IG) or a control group (CG) receiving usual rehabilitation at two different sites; both an urban (IG+CG) and rural site (CG+IG) in Uganda
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Principal investigator, Susanne Guidetti, Karolinska Institutet
- Investigators
- Susanne Guidetti, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337034
- Sponsor's protocol ID
- F@ce 2.0
- Status last verified
- Mar 2024
- First submitted
- 3 Apr 2020
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eriksson G, Kamwesiga JT, Fors U, Oyana T, von Koch L, Ytterberg C, Guidetti S. Implementing and Evaluating a Mobile Phone-Supported and Family-Centered Rehabilitation Program for People With Stroke in Uganda (F@ce 2.0): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 25;13:e60955. doi: 10.2196/60955.
PubMed 39321459
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participation in Everyday Life - A Randomized Controlled Trial of Mobile Phone-supported and Family-centred Rehabilitation After Stroke in Uganda.
- ClinicalTrials.gov ID
- NCT04337034
- Acronym / sponsor ID
- F@ce 2.0
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 7 Apr 2020 (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 purpose of the present proposal is to implement and evaluate a new model for mobile phone supported and family-centred rehabilitation intervention (F@ce 2.0) with regard to functioning in activities in daily living and participation in everyday life among persons with stroke and their families (in rural and urban areas) in Uganda.
Detailed description
The investigators' previous feasibility study suggested beneficial effects on self-efficacy and occupational performance and satisfaction of a mobile phone supported and family-centred rehabilitation intervention (F@ce1.0) after stroke in Uganda. The purpose of the present proposal is to implement and evaluate F@ce on functioning in activities in daily living (ADL) and participation in everyday life among persons with stroke and their families.
With recommendations on evaluation of complex interventions both outcomes and processes will be studied and hence both quantitative and qualitative methods will be applied. In a randomized controlled trial F@ce 2.0 will be evaluated compared to ordinary rehabilitation in urban/rural Uganda regarding; self-efficacy, perceived performance and participation in everyday activities, independence in ADL, health care utilization and the families´ perceived participation in everyday activities. Qualitative data will explore experiences of people with stroke and family members of participating in F@ce 2.0. This research program has a multidisciplinary perspective for sustainable rehabilitation, a prerequisite for better living conditions for people with stroke in low/middle income countries.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to participate in F@ce 2.0 (IG) or a control group (CG) receiving usual rehabilitation at two different sites; both an urban (IG+CG) and rural site (CG+IG) in Uganda
| Arm | Type | Receives |
|---|---|---|
| mobile phone supported and family-centred rehabilitation | Experimental | Behavioral: Mobile phone supported and family-centred rehabilitation, Procedure: Information and blood pressure measurementParticipants in the intervention group will receive an 8-week mobile phone supported and family-centred rehabilitation intervention (F@ce 2.0) |
| Information and blood pressure measurement | Active comparator | Procedure: Information and blood pressure measurementControl group participants will be given information about stroke and their blood pressure will be measured |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- stroke diagnosis identified with CT scan or clinical symptoms
- inhabitant in a rural part of Kalungu District, near Masaka Uganda, or Kampala with surroundings
- access to and ability to use a mobile phone
- ability to speak and express themselves in English and/or Luganda
- Modified Rankin Scale level 2 to 4.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Mobile phone supported and family-centred rehabilitationParticipants in the intervention group will receive an eight-week mobile phone supported and family-centred rehabilitation intervention (F@ce 2.0).The participants will be introduced to a problem-solving strategy intended to facilitate the learning and problem-solving process to be used during the intervention. The strategy will provide a structure for healthcare professionals delivering the intervention. Three targets (goals) in daily activities will be formulated that the person wants and needs to do within the home environment. Each activity will be practiced together with the healthcare professionals and family members. Family members will be informed about the participant's target activities and the planned strategies for reaching the targets. The participants will practice the target activities in their home environment supported by mobile phone calls and SMS. In addition they will be given information about stroke and their blood pressure will be measured. | Behavioural | mobile phone supported and family-centred rehabilitation |
| Information and blood pressure measurementControl group participants will be given information about stroke and their blood pressure will be measured. | Procedure or surgery | Information and blood pressure measurement, mobile phone supported and family-centred rehabilitation |
Primary outcome
Self-efficacy Scale
Time frame: Differences in change between baseline and 3, 6 and 12 months
Participants are instructed to rate how confident they feel about performing each of 16 everyday activities on a 10-point rating scale ranging from 1) "not confident at all in my ability" to 10) "very confident in my ability". The average of all responses are calculated.
3 secondary outcomes
Canadian Occupational Performance Measure (COPM)
Time frame: Differences in change between baseline and 3, 6 and 12 months
Stroke Impact Scale (SIS) 3.0 Uganda version
Time frame: Differences in change between baseline and 3, 6 and 12 months
Barthel Index
Time frame: Differences in change between baseline and 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 39321459Eriksson G, Kamwesiga JT, Fors U, Oyana T, von Koch L, Ytterberg C, Guidetti S. Implementing and Evaluating a Mobile Phone-Supported and Family-Centered Rehabilitation Program for People With Stroke in Uganda (F@ce 2.0): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 25;13:e60955. doi: 10.2196/60955.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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. This study is not recruiting at the moment.
Susanne Guidetti, Professor principal investigator
Karolinska Institutet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone supported and family-centred rehabilitation and Information and blood pressure measurement in people with Stroke, run by Karolinska Institutet at 3 sites in Uganda.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Uganda. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy Scale (time frame: Differences in change between baseline and 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04337034, which also lists 1 linked publication.
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 12 Mar 2024.