Trial Outcomes & Findings for Decisions About Cancer Screening in Alzheimer's Disease (NCT NCT03282097)
NCT ID: NCT03282097
Last Updated: 2025-08-11
Results Overview
The Decisional Conflict Scale (DCS) includes 16-items on a 1-5 Likert scale. Questions are regarding a medical decision that participants have made or that they are about to make; it measures uncertainty around a decision, whether one feels informed, clear about their personal values, and supported in their decision-making It is a validated and widely accepted measure of decision quality that has been used in previous studies of decision aids intended for AD caregivers. Scores can range from 0-100, with lower scores indicating less conflict. This survey is completed during the baseline and Post-Index PCP visit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
442 participants
Primary outcome timeframe
Change in DCS score from Baseline to post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.
Results posted on
2025-08-11
Participant Flow
Participants were recruited from primary care clinics in central Indiana and Boston, MA between November 2017 and August 2022. The first participant was enrolled on December 1, 2017 and the last participant was enrolled on August 29, 2022.
Of the 442 enrolled dyads, 429 were randomized to receive the mammogram decision aid or home safety pamphlet, 427 dyads met inclusion criteria to proceed with the study.
Participant milestones
| Measure |
Mammogram Decision Aid
Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
DECAD decision aid: A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.
|
Home Safety Guide
The home safety guide is a two-page paper pamphlet developed by the American Geriatrics Society Foundation for Health in Aging. It provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards. We selected the home safety guide to account for the attention given to the intervention group but not to provide information that would bias the control group away from talking about mammography with the patient's PCP.
Home safety guide: The home safety guide provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.
|
|---|---|---|
|
Randomized and Completed Baseline
STARTED
|
214
|
215
|
|
Randomized and Completed Baseline
COMPLETED
|
213
|
214
|
|
Randomized and Completed Baseline
NOT COMPLETED
|
1
|
1
|
|
Intervention Visit Complete
STARTED
|
213
|
214
|
|
Intervention Visit Complete
COMPLETED
|
171
|
155
|
|
Intervention Visit Complete
NOT COMPLETED
|
42
|
59
|
|
Primary Outcome Data Collection Complete
STARTED
|
171
|
155
|
|
Primary Outcome Data Collection Complete
COMPLETED
|
168
|
152
|
|
Primary Outcome Data Collection Complete
NOT COMPLETED
|
3
|
3
|
|
15 Month Follow-up Complete
STARTED
|
170
|
155
|
|
15 Month Follow-up Complete
COMPLETED
|
164
|
146
|
|
15 Month Follow-up Complete
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
Mammogram Decision Aid
Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
DECAD decision aid: A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.
|
Home Safety Guide
The home safety guide is a two-page paper pamphlet developed by the American Geriatrics Society Foundation for Health in Aging. It provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards. We selected the home safety guide to account for the attention given to the intervention group but not to provide information that would bias the control group away from talking about mammography with the patient's PCP.
Home safety guide: The home safety guide provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.
|
|---|---|---|
|
Randomized and Completed Baseline
Randomized no Baseline
|
1
|
1
|
|
Intervention Visit Complete
Patient Death
|
13
|
15
|
|
Intervention Visit Complete
Caregiver Death
|
0
|
3
|
|
Intervention Visit Complete
Withdrawal by Subject
|
14
|
13
|
|
Intervention Visit Complete
Became Ineligible before PCP Index visit
|
12
|
21
|
|
Intervention Visit Complete
PCP Index Visit Not Completed
|
3
|
7
|
|
Primary Outcome Data Collection Complete
Missing
|
2
|
3
|
|
Primary Outcome Data Collection Complete
Withdrawal by Subject
|
1
|
0
|
|
15 Month Follow-up Complete
Withdrawal by Subject
|
0
|
1
|
|
15 Month Follow-up Complete
Lost to Follow-up
|
6
|
8
|
Baseline Characteristics
4 participants (caregivers) did not provide age
Baseline characteristics by cohort
| Measure |
Mammogram Decision Aid - Caregivers
n=213 Participants
Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
DECAD decision aid: A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.
|
Mammogram Decision Aid - Patient
n=213 Participants
Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
DECAD decision aid: A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.
|
Home Safety Guide - Caregivers
n=214 Participants
The home safety guide is a two-page paper pamphlet developed by the American Geriatrics Society Foundation for Health in Aging. It provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards. We selected the home safety guide to account for the attention given to the intervention group but not to provide information that would bias the control group away from talking about mammography with the patient's PCP.
Home safety guide: The home safety guide provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.
|
Home Safety Guide - Patient
n=214 Participants
The home safety guide is a two-page paper pamphlet developed by the American Geriatrics Society Foundation for Health in Aging. It provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards. We selected the home safety guide to account for the attention given to the intervention group but not to provide information that would bias the control group away from talking about mammography with the patient's PCP.
Home safety guide: The home safety guide provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.
|
Total
n=854 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
White
|
147 Participants
n=213 Participants
|
150 Participants
n=213 Participants
|
159 Participants
n=214 Participants
|
159 Participants
n=214 Participants
|
615 Participants
n=854 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=213 Participants
|
7 Participants
n=213 Participants
|
4 Participants
n=214 Participants
|
2 Participants
n=214 Participants
|
22 Participants
n=854 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=211 Participants • 4 participants (caregivers) did not provide age
|
0 Participants
n=213 Participants • 4 participants (caregivers) did not provide age
|
0 Participants
n=212 Participants • 4 participants (caregivers) did not provide age
|
0 Participants
n=214 Participants • 4 participants (caregivers) did not provide age
|
0 Participants
n=850 Participants • 4 participants (caregivers) did not provide age
|
|
Age, Categorical
Between 18 and 65 years
|
146 Participants
n=211 Participants • 4 participants (caregivers) did not provide age
|
0 Participants
n=213 Participants • 4 participants (caregivers) did not provide age
|
139 Participants
n=212 Participants • 4 participants (caregivers) did not provide age
|
0 Participants
n=214 Participants • 4 participants (caregivers) did not provide age
|
285 Participants
n=850 Participants • 4 participants (caregivers) did not provide age
|
|
Age, Categorical
>=65 years
|
65 Participants
n=211 Participants • 4 participants (caregivers) did not provide age
|
213 Participants
n=213 Participants • 4 participants (caregivers) did not provide age
|
73 Participants
n=212 Participants • 4 participants (caregivers) did not provide age
|
214 Participants
n=214 Participants • 4 participants (caregivers) did not provide age
|
565 Participants
n=850 Participants • 4 participants (caregivers) did not provide age
|
|
Sex/Gender, Customized
Female
|
133 Participants
n=213 Participants
|
213 Participants
n=213 Participants
|
131 Participants
n=214 Participants
|
214 Participants
n=214 Participants
|
691 Participants
n=854 Participants
|
|
Sex/Gender, Customized
Male
|
80 Participants
n=213 Participants
|
0 Participants
n=213 Participants
|
82 Participants
n=214 Participants
|
0 Participants
n=214 Participants
|
162 Participants
n=854 Participants
|
|
Sex/Gender, Customized
Other
|
0 Participants
n=213 Participants
|
0 Participants
n=213 Participants
|
1 Participants
n=214 Participants
|
0 Participants
n=214 Participants
|
1 Participants
n=854 Participants
|
|
Race/Ethnicity, Customized
African American
|
57 Participants
n=213 Participants
|
55 Participants
n=213 Participants
|
51 Participants
n=214 Participants
|
53 Participants
n=214 Participants
|
216 Participants
n=854 Participants
|
|
Race/Ethnicity, Customized
No response provided
|
0 Participants
n=213 Participants
|
1 Participants
n=213 Participants
|
0 Participants
n=214 Participants
|
0 Participants
n=214 Participants
|
1 Participants
n=854 Participants
|
|
Region of Enrollment
United States
|
213 participants
n=213 Participants
|
213 participants
n=213 Participants
|
214 participants
n=214 Participants
|
214 participants
n=214 Participants
|
854 participants
n=854 Participants
|
PRIMARY outcome
Timeframe: Change in DCS score from Baseline to post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.Population: The above values represent the number of dyads that completed the Decisional Conflict Scale (DCS) at both baseline and post-PCP Index Visit.
The Decisional Conflict Scale (DCS) includes 16-items on a 1-5 Likert scale. Questions are regarding a medical decision that participants have made or that they are about to make; it measures uncertainty around a decision, whether one feels informed, clear about their personal values, and supported in their decision-making It is a validated and widely accepted measure of decision quality that has been used in previous studies of decision aids intended for AD caregivers. Scores can range from 0-100, with lower scores indicating less conflict. This survey is completed during the baseline and Post-Index PCP visit.
Outcome measures
| Measure |
Mammogram Decision Aid
n=167 Participants
Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
DECAD decision aid: A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.
|
Home Safety Guide
n=152 Participants
The home safety guide is a two-page paper pamphlet developed by the American Geriatrics Society Foundation for Health in Aging. It provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards. We selected the home safety guide to account for the attention given to the intervention group but not to provide information that would bias the control group away from talking about mammography with the patient's PCP.
Home safety guide: The home safety guide provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.
|
|---|---|---|
|
Decisional Conflict Scale
|
-1.9 Units on DCS scale
Standard Deviation 16.1
|
-0.8 Units on DCS scale
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Change in Decision Self-Efficacy score from Baseline to post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.Population: The above values represent the number of dyads that completed the Decision Self-Efficacy Scale (DSE) at both baseline and post-PCP Index Visit.
To measure decision-making self-efficacy, we will use the Decision Self-Efficacy Scale (DSE). The DSE is a validated, 11-item instrument that measures how confident the respondent is in their ability to make an informed medical decision, including SDM. We will adapt the DSE with five response categories on a 0-4 Likert scale ("not at all confident", "somewhat confident", "neither confident nor not confident", "confident", and "very confident") to measure caregiver decision-making self-efficacy for mammography decisions for their relative with Alzheimer's Disease and related dementias. To score the sum of all items are divided by 11 and multiplied by 25. Scores range from 0 (Extremely low self-efficacy) to 100 (Extremely high self-efficacy). To measure the change in self-efficacy over time in both groups, we will measure it at two time points.
Outcome measures
| Measure |
Mammogram Decision Aid
n=167 Participants
Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
DECAD decision aid: A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.
|
Home Safety Guide
n=152 Participants
The home safety guide is a two-page paper pamphlet developed by the American Geriatrics Society Foundation for Health in Aging. It provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards. We selected the home safety guide to account for the attention given to the intervention group but not to provide information that would bias the control group away from talking about mammography with the patient's PCP.
Home safety guide: The home safety guide provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.
|
|---|---|---|
|
Change in Decision-making Self-efficacy Scale Score
|
-1.7 Units on the DSE scale
Standard Deviation 14.6
|
0.0 Units on the DSE scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: The above values represent the number of caregivers that completed the assessment at post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.Population: Caregivers who completed post-PCP Index Visit.
On a scale from 1 to 10, caregivers assessed the role that they have in decision making for the patient. The scale is 1 to 10 where 1 means the patient makes all the medical decisions on her own, 5 means that the patient and caregiver equally share the medical decisions, and 10 means that the caregiver makes all medical decisions for the patient.
Outcome measures
| Measure |
Mammogram Decision Aid
n=168 Participants
Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
DECAD decision aid: A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.
|
Home Safety Guide
n=152 Participants
The home safety guide is a two-page paper pamphlet developed by the American Geriatrics Society Foundation for Health in Aging. It provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards. We selected the home safety guide to account for the attention given to the intervention group but not to provide information that would bias the control group away from talking about mammography with the patient's PCP.
Home safety guide: The home safety guide provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.
|
|---|---|---|
|
Caregiver Role in Decision Making
|
5.7 units on a scale
Standard Deviation 1.6
|
5.2 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 15 month post interventionPopulation: All patients who completed an index visit
Receipt of mammograms was assessed 15 months post intervention.
Outcome measures
| Measure |
Mammogram Decision Aid
n=171 Participants
Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
DECAD decision aid: A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.
|
Home Safety Guide
n=155 Participants
The home safety guide is a two-page paper pamphlet developed by the American Geriatrics Society Foundation for Health in Aging. It provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards. We selected the home safety guide to account for the attention given to the intervention group but not to provide information that would bias the control group away from talking about mammography with the patient's PCP.
Home safety guide: The home safety guide provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.
|
|---|---|---|
|
Receipt of Mammogram Screening
Received mammogram
|
32 Participants
|
33 Participants
|
|
Receipt of Mammogram Screening
Did not receive mammogram
|
139 Participants
|
122 Participants
|
SECONDARY outcome
Timeframe: Change in Caregiver knowledge from Baseline to post-PCP Index Visit. Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.Population: The above values represent the number of caregivers that completed the knowledge assessment at both baseline and post-PCP Index Visit.
Knowledge about mammograms for older women with Alzheimer's Disease and Related Dementias will be measured with a 16-item measure (6 multiple choice and 10 true/false) mapped directly from the information presented in the decision aid. Scoring for this study created measure is the sum of the correct responses.
Outcome measures
| Measure |
Mammogram Decision Aid
n=168 Participants
Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
DECAD decision aid: A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.
|
Home Safety Guide
n=152 Participants
The home safety guide is a two-page paper pamphlet developed by the American Geriatrics Society Foundation for Health in Aging. It provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards. We selected the home safety guide to account for the attention given to the intervention group but not to provide information that would bias the control group away from talking about mammography with the patient's PCP.
Home safety guide: The home safety guide provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.
|
|---|---|---|
|
Change in Caregiver Knowledge About Mammograms in Older Women With ADRD
|
1.4 Units on the scale
Standard Deviation 2.4
|
0.1 Units on the scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Post-PCP Index visit routinely occurs 0-5 days after the patient's index visit with their PCP.Population: The above values represent the number of caregivers that completed the assessment at post-PCP Index Visit.
Caregivers were asked when they believed the patient would receive their next mammogram. Never responses were labeled as no, and responses that indicated an intention to be screened in the future were labeled as yes.
Outcome measures
| Measure |
Mammogram Decision Aid
n=159 Participants
Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
DECAD decision aid: A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.
|
Home Safety Guide
n=141 Participants
The home safety guide is a two-page paper pamphlet developed by the American Geriatrics Society Foundation for Health in Aging. It provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards. We selected the home safety guide to account for the attention given to the intervention group but not to provide information that would bias the control group away from talking about mammography with the patient's PCP.
Home safety guide: The home safety guide provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.
|
|---|---|---|
|
Caregiver Intention for the Patient to Receive Mammogram Screening in the Future
Yes
|
73 Participants
|
104 Participants
|
|
Caregiver Intention for the Patient to Receive Mammogram Screening in the Future
No
|
86 Participants
|
37 Participants
|
Adverse Events
Mammogram Decision Aid - Patient
Serious events: 1 serious events
Other events: 4 other events
Deaths: 37 deaths
Mammogram Decision Aid - Caregiver
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Home Safety Guide - Patient
Serious events: 2 serious events
Other events: 4 other events
Deaths: 30 deaths
Home Safety Guide - Caregiver
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Mammogram Decision Aid - Patient
n=213 participants at risk
Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
DECAD decision aid: A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.
|
Mammogram Decision Aid - Caregiver
Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
DECAD decision aid: A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.
|
Home Safety Guide - Patient
n=214 participants at risk
The home safety guide is a two-page paper pamphlet developed by the American Geriatrics Society Foundation for Health in Aging. It provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards. We selected the home safety guide to account for the attention given to the intervention group but not to provide information that would bias the control group away from talking about mammography with the patient's PCP.
Home safety guide: The home safety guide provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.
|
Home Safety Guide - Caregiver
The home safety guide is a two-page paper pamphlet developed by the American Geriatrics Society Foundation for Health in Aging. It provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards. We selected the home safety guide to account for the attention given to the intervention group but not to provide information that would bias the control group away from talking about mammography with the patient's PCP.
Home safety guide: The home safety guide provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
New Breast Cancer Diagnosis
|
0.47%
1/213 • All adverse events, unanticipated problems and potential risks will be monitored and collected ongoing and throughout the study by the DECAD research staff and coordinators. For all patients, adverse events will be collected starting at enrollment and continue until after the patient has completed the study either by completing the 15-month follow up or 24-months post-Primary Outcome Data Collection.
Adverse events or serious adverse events are only collected for the patient in each dyad.
|
—
0/0 • All adverse events, unanticipated problems and potential risks will be monitored and collected ongoing and throughout the study by the DECAD research staff and coordinators. For all patients, adverse events will be collected starting at enrollment and continue until after the patient has completed the study either by completing the 15-month follow up or 24-months post-Primary Outcome Data Collection.
Adverse events or serious adverse events are only collected for the patient in each dyad.
|
0.93%
2/214 • All adverse events, unanticipated problems and potential risks will be monitored and collected ongoing and throughout the study by the DECAD research staff and coordinators. For all patients, adverse events will be collected starting at enrollment and continue until after the patient has completed the study either by completing the 15-month follow up or 24-months post-Primary Outcome Data Collection.
Adverse events or serious adverse events are only collected for the patient in each dyad.
|
—
0/0 • All adverse events, unanticipated problems and potential risks will be monitored and collected ongoing and throughout the study by the DECAD research staff and coordinators. For all patients, adverse events will be collected starting at enrollment and continue until after the patient has completed the study either by completing the 15-month follow up or 24-months post-Primary Outcome Data Collection.
Adverse events or serious adverse events are only collected for the patient in each dyad.
|
Other adverse events
| Measure |
Mammogram Decision Aid - Patient
n=213 participants at risk
Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
DECAD decision aid: A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.
|
Mammogram Decision Aid - Caregiver
Will be mailed the DECAD decision aid before their next PCP visit in order to better inform their decision to continue or stop mammography.
DECAD decision aid: A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.
|
Home Safety Guide - Patient
n=214 participants at risk
The home safety guide is a two-page paper pamphlet developed by the American Geriatrics Society Foundation for Health in Aging. It provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards. We selected the home safety guide to account for the attention given to the intervention group but not to provide information that would bias the control group away from talking about mammography with the patient's PCP.
Home safety guide: The home safety guide provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.
|
Home Safety Guide - Caregiver
The home safety guide is a two-page paper pamphlet developed by the American Geriatrics Society Foundation for Health in Aging. It provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards. We selected the home safety guide to account for the attention given to the intervention group but not to provide information that would bias the control group away from talking about mammography with the patient's PCP.
Home safety guide: The home safety guide provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Complications and distress of receiving a mammogram
|
1.9%
4/213 • All adverse events, unanticipated problems and potential risks will be monitored and collected ongoing and throughout the study by the DECAD research staff and coordinators. For all patients, adverse events will be collected starting at enrollment and continue until after the patient has completed the study either by completing the 15-month follow up or 24-months post-Primary Outcome Data Collection.
Adverse events or serious adverse events are only collected for the patient in each dyad.
|
—
0/0 • All adverse events, unanticipated problems and potential risks will be monitored and collected ongoing and throughout the study by the DECAD research staff and coordinators. For all patients, adverse events will be collected starting at enrollment and continue until after the patient has completed the study either by completing the 15-month follow up or 24-months post-Primary Outcome Data Collection.
Adverse events or serious adverse events are only collected for the patient in each dyad.
|
1.9%
4/214 • All adverse events, unanticipated problems and potential risks will be monitored and collected ongoing and throughout the study by the DECAD research staff and coordinators. For all patients, adverse events will be collected starting at enrollment and continue until after the patient has completed the study either by completing the 15-month follow up or 24-months post-Primary Outcome Data Collection.
Adverse events or serious adverse events are only collected for the patient in each dyad.
|
—
0/0 • All adverse events, unanticipated problems and potential risks will be monitored and collected ongoing and throughout the study by the DECAD research staff and coordinators. For all patients, adverse events will be collected starting at enrollment and continue until after the patient has completed the study either by completing the 15-month follow up or 24-months post-Primary Outcome Data Collection.
Adverse events or serious adverse events are only collected for the patient in each dyad.
|
Additional Information
Nicole R. Fowler, PhD, MHSA; Associate Professor of Medicine
Indiana University School of Medicine; Indiana University Center for Aging Research; Regenstrief Institute, Inc.
Phone: 317-274-9021
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place