Background
Method
Design
Measurements
Survey
Focus groups
Data analysis
Results
Survey
Participant characteristics
Characteristics | All survey respondents | Alzheimer dementia | Mild cognitive impairment | Cognitively normal | p-value |
---|---|---|---|---|---|
N | 71 | 33 | 19 | 19 | |
Age, mean (±SD) | 68.7 (6.5) Range = 51–82 | 67.6 (7.9) Range = 51–81 | 68.8 (8.8) Range = 53–82 | 69.9 (4.1) b Range = 63–82 | .56 |
Female, n (%) | 38 (54) | 21 (64) | 10 (53) | 7 (37) | .17 |
Education level, n (%) | .18 | ||||
Up to secondary school completed | 23 (32) | 13 (39) | 6 (32) | 4 (21) | |
Vocational training, diploma | 11 (16) | 5 (15) | 5 (26) | 1 (5) | |
University degree | 37 (52) | 15 (46) | 8 (42) | 14 (74) | |
Participated in a number of clinical trials | |||||
1/2/3, n | 45/17/ 9 | 19/9/5 | 9/6/4 | 17/2/0 | .02^ |
Completed participation in clinical triala | 32 (45%) | 18 (55%) | 7 (37%) | 7 (37%) | .15 |
Study partner | 19 (7%) | 16 (49%) | 3 (16%) | 0 (0%) | <.01 |
Rationale and motives
Most important reason to participate in a clinical trial | Overall | Alzheimer’s disease | Mild Cognitive impairment | Cognitively normal | ||||
---|---|---|---|---|---|---|---|---|
N | % (ntotal=71) | n | % (nAD=33) | n | % (nMCI=19) | n | % (nCN=19) | |
For the future generation | 63 | 88.7% | 28 | 94.3% | 17 | 98.5% | 18 | 94.7% |
For science | 47 | 66.2% | 21 | 63.6% | 15 | 78.9% | 11 | 57.9% |
I think I will be monitored better | 30 | 42.3% | 14 | 91.5% | 9 | 47.4% | 7 | 36.8% |
I find it interesting | 22 | 31.0% | 12 | 36.4% | 162 | 39.7% | 5 | 26.3% |
My doctor recommended it | 7 | 9.9% | 5 | 15.2% | 2 | 10.5% | 0 | 0.0% |
I think it is the best treatment | 7 | 9.9% | 5 | 15.2% | 2 | 10.5% | 0 | 0.0% |
To receive better care | 7 | 9.9% | 4 | 12.1% | 2 | 10.5% | 1 | 5.3% |
It is a useful time to spend the day | 2 | 2.8% | 2 | 6.1% | 0 | 0.0% | 0 | 0% |
Suggestions for increasing willingness to participate
What would make participation easier for you or others? | Overall | Alzheimer’s disease | Mild Cognitive impairment | Cognitively normal | ||||
---|---|---|---|---|---|---|---|---|
N | % (ntotal=71) | n | % (nAD=33) | n | % (nMCI=19) | n | % (nCN=19) | |
Less chance to receive placebo | 38 | 53.5% | 18 | 54.5% | 13 | 68.4% | 7 | 36.8% |
Shorter travel time | 27 | 38.0% | 14 | 42.4% | 6 | 31.6% | 7 | 36.8% |
Less frequent lumbar puncture | 22 | 31.0% | 12 | 36.4% | 4 | 21.1% | 6 | 31.6% |
Home visits | 12 | 16.9% | 9 | 27.3% | 2 | 10.5% | 1 | 5.3% |
Less frequent visits to center | 6 | 8.5% | 5 | 15.2% | 1 | 5.3% | 0 | 0.0% |
Study partner burden | 9 | 12.7% | 4 | 12.1% | 1 | 5.3% | 4 | 21.1% |
Less frequent MRI scan | 8 | 11.3% | 3 | 9.1% | 1 | 5.3% | 4 | 21.1% |
Less frequent PET scan | 6 | 8.5% | 3 | 9.1% | 1 | 5.3% | 2 | 10.5% |
More compensation | 5 | 7.0% | 1 | 3.0% | 4 | 21.1% | 0 | 0% |
Less frequent memory assessments | 4 | 5.6% | 2 | 6.1% | 1 | 5.3% | 1 | 5.3% |
Less frequent depression assessments | 2 | 2.8% | 0 | 0% | 2 | 10.5% | 0 | 0% |
What are the most important factors when considering to enrol again? | Overall | Alzheimer’s disease | Mild Cognitive impairment | Cognitively normal | ||||
---|---|---|---|---|---|---|---|---|
N | % (ntotal=71) | n | % (nAD=33) | n | % (nMCI=19) | n | % (nCN=19) | |
Sharing personal results | 57 | 80.3% | 24 | 72.7% | 16 | 84.2% | 17 | 89.5% |
Sharing research results | 52 | 73.2% | 22 | 66.7% | 16 | 84.2% | 14 | 73.7% |
Possibility to enrol in a new trial | 45 | 63.4% | 24 | 72.7% | 13 | 68.4% | 8 | 42.1% |
The same specialist each visit | 41 | 57.7% | 18 | 54.5% | 13 | 68.4% | 10 | 52.6% |
Reputation research center | 34 | 47.9% | 16 | 48.5% | 10 | 52.6% | 8 | 42.1% |
Number of visits to center per month | 11 | 15.5% | 7 | 21.2% | 4 | 21.1% | 0 | 0% |
Side effects | 10 | 14.1% | 3 | 9.1% | 4 | 21.1% | 3 | 15.8% |
Distance to study center | 8 | 11.3% | 4 | 12.1% | 3 | 15.8% | 1 | 5.3% |
Chance to receive placebo | 8 | 11.3% | 4 | 12.1% | 4 | 21.1% | 0 | 0% |
To receive payment | 4 | 5.6% | 2 | 6.1% | 2 | 10.5% | 0 | 0% |
Duration of study visit | 4 | 5.6% | 3 | 9.1% | 1 | 5.3% | 0 | 0% |
Privacy | 3 | 4.2% | 1 | 3.0% | 2 | 10.5% | 0 | 0% |
Preferred frequency of visits and trial duration
Patient burden
Focus groups
Positive and negative aspects of participating
Experienced negative aspects | Summed score | Frequency top 5 | Experienced positive aspects | Summed score | Frequency top 5 |
---|---|---|---|---|---|
Communication test results during or after participating | 75/120 | 7/12 | Empathy employees research center | 107/120 | 8/12 |
Lumbar puncture | 75/120 | 5/12 | Contribute to a possible cure for Alzheimer’s disease | 74/120 | 6/12 |
Cognitive assessments | 70/120 | 4/12 | Personal treatment | 68/120 | 1/12 |
Communication regarding the result of genetic testing/diagnosis | 70/120 | 3/12 | Professionalism of research team | 66/120 | 6/12 |
Study stopped without result | 62/120 | 2/12 | A hearty greeting of reception | 65/120 | 4/12 |
Appreciation pharmaceutical company | 41/120 | 1/12 | More time/attention than in hospital | 57/120 | 5/12 |
MRI scan | 38/120 | 3/12 | Provide lunch | 49/120 | 1/12 |
Results of neuropsychological assessments are confronting | 37/120 | 1/12 | Keep track of brain condition | 47/120 | 2/12 |
Study partner burden | 36/120 | 3/12 | Attention physical condition | 46/120 | 4/12 |
Little interest in motivation of participants | 34/120 | 1/12 | Scientific approach to research | 46/120 | 2/12 |
Lack of follow-up measurements after and at the end of the study | 26/120 | 3/12 | Atmosphere research location | 46/120 | 0/12 |
Lack of empathy of staff outside of research center | 25/120 | 1/12 | Supervision and guidance research team | 44/120 | 1/12 |
PET scan | 21/120 | 1/12 | Neuropsychological assessments | 43/120 | 0/12 |
Travel distance to research center | 21/120 | 3/12 | Study partner involved | 36/120 | 1/12 |
Not working devices | 19/120 | 0/12 | Frequency of visits | 28/120 | 0/12 |
(unannounced) Changes in research personnel | 18/120 | 2/12 | Feedback abnormal results | 26/120 | 3/12 |
Temperature research center | 15/120 | 0/12 | The distance from the study site | 25/120 | 0/12 |
Starting too early | 11/120 | 3/12 | No pressure, always possibility to stop participation | 20/120 | 0/12 |
No hierarchy | 19/120 | 4/12 |
Clinical trial design
Female, 63, CN: I would like to know how I am doing after the trial. Is it going well or am I getting worse?.
Male, 70, CN: I wanted to know how I was doing since the trial stopped suddenly. Therefore, follow up visits after participating would be nice.
Male, 73, CN: Communciation is very important. In the beginning I did not understand what it meant to be an APOE E4 carrier.
Female, 67, CN: Trial duration is most determative for me when participating in a trial, I would rather participate in a trial of longer duration.
Male, 73, CN: I do not like the idea that you get involved in a clinical trial for 5 years and at the end it turns out you had a placebo.
Female 76, MCI: A one year trial is perfect for me. If it then turns out the medicine is not working, I will participate in a next clinical trial.
Female, 63, CN: The memory assessment were very hard for me, especially the one you have to remember 15 words felt as failing. I almost started crying.
Male, 68, CN: I had a headache for one week after the lumbar puncture.
Female, 65, MCI: I would really appreciate being guided by the same people as much as possible.
Male, 76, CN: I was very happy with the professionalism and adequacy of the research staff.
Male, 68, CN: I thought it was striking that there was no interest in my reasons to enroll in a clinical trial. For me it was very important that the research staff knew why I participated.
Male, 70, CN: You will not have any personal contact with the pharmaceutical company, but you have to sign all these papers for them, that feels wrong.
Male, 70, MCI: Negative publicity of the pharmaceutical company (making large financial gains) affected my willingness to participate in the trial.