Improving Prospective Memory Via Telehealth
Improving Prospective Memory Via Telehealth: A Randomized Feasibility Trial
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Memory for Intentions Test Time Cue Subscale Percentile | 0.040 | ||
| Memory for Intentions Test Total Score Percentile | 0.229 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Prospective Memory Intervention
Compared with
- Educational
Results by group
Memory for Intentions Test Total Score Percentile
Six weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Prospective Memory Intervention | 32.24 Percentile | 21.78 (Standard Deviation) | 17 |
| Educational | 38.94 Percentile | 24.29 (Standard Deviation) | 18 |
| Prospective Memory Intervention | 35.02 Percentile | 22.77 (Standard Deviation) | 17 |
| Educational | 45.40 Percentile | 36.62 (Standard Deviation) | 18 |
Prospective Memory Intervention
Educational
Prospective Memory Intervention
Educational
p = 0.229
Memory for Intentions Test Time Cue Subscale Percentile
Six weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Prospective Memory Intervention | 35.00 Percentile | 19.75 (Standard Deviation) | 17 |
| Educational | 51.78 Percentile | 24.09 (Standard Deviation) | 18 |
| Prospective Memory Intervention | 57.89 Percentile | 30.53 (Standard Deviation) | 17 |
| Educational | 59.52 Percentile | 29.89 (Standard Deviation) | 18 |
Prospective Memory Intervention
Educational
Prospective Memory Intervention
Educational
p = 0.040
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Prospective Memory Intervention | 17 | 0 (0.0%) | 0 |
| Educational | 18 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Memory for Intentions Test Total Score Percentile
Six weeks
Thinking and memoryMemory for Intentions Test Time Cue Subscale Percentile
Six weeks
Thinking and memory
Other measures (1)
Perceived Deficits Questionnaire-Prospective Memory Subscale
Six weeks
Thinking and memory
Who could take part
MS (type not specified) · 18 to 60
Show the full criteria
Inclusion criteria
* Clinical diagnosis of MS * Able to read, write, and speak in English * Between the ages of 18 and 60 * All genders * No history of other serious neurologic or psychiatric illness, including drug or alcohol misuse * No relapses within the past two months * Access to the Internet and a web camera * Not enrolled in a cognitive rehabilitation program within the past six months * Self-reported issues "remembering places they have to be" and "things they have to do"
Exclusion criteria
* No diagnosis of MS * Unable to complete the study protocol due to language barriers * Younger than 18 or older than 61 * No gender exclusions * History of other serious neurologic or psychiatric illness, including drug or alcohol misuse * Had a relapse within the past two months * No access to the Internet and/or a web camera * Currently enrolled or enrolled in a cognitive rehabilitation program within the past six months * No self-reported issues with "remembering places they have to be" or "things they have to do"
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Up to 70% of persons with multiple sclerosis (PwMS) experience cognitive impairment, which can have a significant impact on several aspects of their daily lives. One cognitive domain that has been shown to impact daily functioning, but is understudied in MS, is prospective memory (PM). While there have been successful PM interventions in other clinical populations, to date there has not been a specific PM intervention for PwMS that has been tested in a clinical trial. The study will be a double-masked randomized feasibility trial, with 18 participants randomized to a PM intervention and 18 participants randomized to an active control (psychoeducation). Participants will meet with an interventionist twice a week for four weeks. Feasibility will be assessed via 1) recruitment, enrollment, and retention; 2) adherence to the treatment; 3) treatment credibility and expectancy; and 4) treatment satisfaction. A preliminary effect size (Cohen's d) will be computed for the group difference using participants' performance on the Memory for Intentions Test, which will be given at baseline (week 1) and post-treatment (week 6). Participants will also complete a battery of neuropsychological measures as part of their baseline and post-treatment assessments.
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History
Started
Nov 2021
Main results due
Jun 2023
Finished
Jun 2023
Results posted
Oct 2024