Trial Outcomes & Findings for IDEA Study Cognitive Stimulation Therapy (CST) Trial in Nigeria (NCT NCT02233530)
NCT ID: NCT02233530
Last Updated: 2021-06-21
Results Overview
Quality of life assessment in patients and carers. The minimum score is 4 and the maximum 20, with a higher score signifying better quality of life.
COMPLETED
NA
8 participants
Baseline
2021-06-21
Participant Flow
Participant milestones
| Measure |
CST Intervention
Outcomes at baseline will be compared with those immediately post intervention and at four weeks post-intervention.
In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. The investigators will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location. Individuals will be allocated to groups based on religion, gender and geographical location.
CST intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life. Sessions will be led and facilitated by a study nurse or occupational therapist. The sessions will be held at a local health centre of village hall.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IDEA Study Cognitive Stimulation Therapy (CST) Trial in Nigeria
Baseline characteristics by cohort
| Measure |
Intervention
n=9 Participants
Cognitive stimulation therapy participants. Participant received two sessions per week for seven weeks, with 14 sessions in total. Each session lasted between 45 and 60 minutes.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
81 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Nigeria
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: All baseline participants
Quality of life assessment in patients and carers. The minimum score is 4 and the maximum 20, with a higher score signifying better quality of life.
Outcome measures
| Measure |
Intervention
n=9 Participants
Intervention group
|
|---|---|
|
World Health Organization Brief Quality of Life Measure (WHOQOL-Bref)
|
10.3 units on a scale
Interval 9.4 to 12.9
|
PRIMARY outcome
Timeframe: An average of eight weeks from baselinePopulation: All baseline participants
Quality of life assessment in patients and carers. The minimum score is 4 and the maximum 20, with a higher score signifying better quality of life.
Outcome measures
| Measure |
Intervention
n=9 Participants
Intervention group
|
|---|---|
|
World Health Organization Brief Quality of Life Measure (WHOQOL-Bref)
|
14.9 units on a scale
Interval 12.3 to 16.0
|
SECONDARY outcome
Timeframe: An average of twelve weeks from baselineQuality of life assessment in patients and carers. The minimum score is 4 and the maximum 20, with a higher score signifying better quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineCognitive assessment in patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: An average of eight weeks from baselineCognitive assessment in patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: An average of twelve weeks from baselineCognitive assessment in patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineAnxiety and depression assessment in patients and carers. The minimum score is 0 and the maximum 42, with a higher score signifying greater depression.
Outcome measures
| Measure |
Intervention
n=9 Participants
Intervention group
|
|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
|
21 units on a scale
Interval 19.0 to 21.5
|
SECONDARY outcome
Timeframe: An average of eight weeks from baselineAnxiety and depression assessment in patients and carers. The minimum score is 0 and the maximum 42, with a higher score signifying greater depression.
Outcome measures
| Measure |
Intervention
n=9 Participants
Intervention group
|
|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
|
20 units on a scale
Interval 18.5 to 21.0
|
SECONDARY outcome
Timeframe: An average of twelve weeks from baselineAnxiety and depression assessment in patients and carers
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineCarer burden assessment. The minimum score is 0 and the maximum 48, with a higher score signifying greater carer burden.
Outcome measures
| Measure |
Intervention
n=9 Participants
Intervention group
|
|---|---|
|
Zarit Burden Interview (ZBI)
|
18 units on a scale
Interval 10.0 to 35.5
|
SECONDARY outcome
Timeframe: An average of eight weeks from baselineCarer burden assessment. The minimum score is 0 and the maximum 48, with a higher score signifying greater carer burden.
Outcome measures
| Measure |
Intervention
n=9 Participants
Intervention group
|
|---|---|
|
Zarit Burden Interview (ZBI)
|
11 units on a scale
Interval 7.5 to 18.0
|
SECONDARY outcome
Timeframe: An average of twelve weeks from baselineCarer burden assessment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineCognitive assessment in patients. The minimum score is 0 and the maximum 70, with a lower score signifying better cognition.
Outcome measures
| Measure |
Intervention
n=9 Participants
Intervention group
|
|---|---|
|
Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)
|
12 units on a scale
Interval 5.5 to 35.5
|
SECONDARY outcome
Timeframe: An average of eight weeks from baselineCognitive assessment in patients. The minimum score is 0 and the maximum 70, with a lower score signifying better cognition.
Outcome measures
| Measure |
Intervention
n=9 Participants
Intervention group
|
|---|---|
|
Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)
|
7 units on a scale
Interval 3.5 to 10.5
|
SECONDARY outcome
Timeframe: An average of twelve weeks from baselineCognitive assessment in patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineAssessment of health service utilisation and time and travel for patients and carers
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: An average of twelve weeks from baselineAssessment of health service utilisation and time and travel for patients and carers
Outcome measures
Outcome data not reported
Adverse Events
Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Adesola Ogunniyi
University of Ibadan, Ibadan, Nigeria
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place